Exact FDA event identifier

Event 75415

9 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 27, 2016
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: North American Rescue LLC.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 9

Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue

D-0175-2017

Recall number: D-0175-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

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

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 2 of 9

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

D-0176-2017

Recall number: D-0176-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

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

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 3 of 9

Range Trauma Kit - Product Code 85-1274, North American Rescue

D-0177-2017

Recall number: D-0177-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

Kit Part # 85-1274 - Kit Lot # 85-1274072516W

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 4 of 9

Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

D-0178-2017

Recall number: D-0178-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

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

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 5 of 9

K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue

D-0179-2017

Recall number: D-0179-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

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

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 6 of 9

Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

D-0180-2017

Recall number: D-0180-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

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

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 7 of 9

Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue

D-0181-2017

Recall number: D-0181-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

Kit Part # 85-0835 - Kit Lot # 85-0835061016, 85-0835052416, 85-0835051116, 85-0835050216, 85-0835042916, 85-0835072616, 85-0835072016

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 8 of 9

Aid Backpack Kit - Product Code 85-0917, North American Rescue

D-0182-2017

Recall number: D-0182-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

Kit Part # 85-0917 - Kit Lot # 85-0917041916

Distribution pattern

Nationwide, Australia & Switzerland

drug · product 9 of 9

USCG Boat Response Kit - Product Code 80-0353, North American Rescue

D-0183-2017

Recall number: D-0183-2017
Initiated: September 27, 2016
Classification: Class II
Status: Terminated
Recalling firm: North American Rescue LLC.
Quantity: unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Code information

Kit Part # 80-0353 - Kit Lot # 80-0353051916

Distribution pattern

Nationwide, Australia & Switzerland