Multi-event September 2016 FDA Recall Drug by North American Rescue Llc.
This Multi-event Class II drug recall was voluntarily initiated by North American Rescue Llc. on September 27, 2016 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-0176-2017 D-0181-2017 D-0180-2017 D-0178-2017 D-0179-2017 D-0183-2017 D-0182-2017 D-0177-2017 D-0175-2017
Recall Number: D-0176-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 80-0213 - Kit
Lot# 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit
Lot# 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit
Lot# 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W
Recall Number: D-0181-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 85-0835 - Kit
Lot# 85-0835061016, 85-0835052416, 85-0835051116, 85-0835050216, 85-0835042916, 85-0835072616, 85-0835072016
Recall Number: D-0180-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 85-0639 - Kit
Lot# 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639091316
Recall Number: D-0178-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 85-0742 Kit
Lot# 85-0742071816; Kit Part # 85-0748 Kit
Lot# 85-0746061016; Kit Part # 85-0745 - Kit
Lot# 85-0745042516; Kit Part # 85-0639 - Kit
Lot# 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639090716, 85-0639080116, 85-0639091316; Kit Part # 85-0744 - Kit
Lot# 85-0744072516, 85-0744060916, 85-0744052516; Kit Part # 85-0741- Kit
Lot# 85-0741071416
Recall Number: D-0179-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 80-0211 - Kit
Lot# 80-0211070616, 80-0211051316, 80-0211041816, 80-0211030216, 80-0211072216, 80-0210070716, 80-0210050416W, 80-0210072216; Kit Part # 80-0304 - Kit
Lot# 80-0304041916; Kit Part # 80-0209 - Kit
Lot# 80-0209082216, 80-0209051816, 80-0209051616, 80-029050316, 80-0209041916, 80-0209060316; Kit Part # 80-210 Kit
Lot# 80-021007076, 80-0210050416W, 80-0210072216; Kit Part # 80-0300 - Kit
Lot# 80-0300081216, 80-0300050916, 80-0300050316, 80-0300041916, 80-0300082416; Kit Part #80-0301 - Kit
Lot# 80-0301042916, 80-0301050316
Recall Number: D-0183-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
USCG Boat Response Kit - Product Code 80-0353, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 80-0353 - Kit
Lot# 80-0353051916
Recall Number: D-0182-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Aid Backpack Kit - Product Code 85-0917, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 85-0917 - Kit
Lot# 85-0917041916
Recall Number: D-0177-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Range Trauma Kit - Product Code 85-1274, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 85-1274 - Kit
Lot# 85-1274072516W
Recall Number: D-0175-2017
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
09-27-2016
12-14-2016
unknown
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
North American Rescue LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, Australia & Switzerland
03-09-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
Batch or Lot Expiration Information
Lot# Kit Part # 85-0889 - Kit
Lot# 85-0889082416, 85-0889071816, 85-0889071916, 85-0889071416, 85-0889052316, 85-0889050416, 85-0889042016, 85-0889041416, 85-0889090616, 85-0889090716, 85-0889060216, 85-0889062216, 85-0889080116, 85-0889080816
