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Open, Classified

Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box

FDA Recall Z-0525-2019 · Posted None

Recalling FirmASO, LLC
Recall StatusOpen, Classified
Product CodeNAB
Date Initiated2018-10-16
Product Quantity218 cases (72, 10-ct boxes per case)

Reason for Recall

Potential that gauze pads may not be fully sterilized

Firm Action

ASO, LLC notified customers of the recall on about 10/16/2018 via "URGENT: MEDICAL DEVICE RECALL" letter sent to corporate. Instructions were to immediately stop using/distributing the affected gauze pads, place them in quarantine, and return to ASO LLC. Customers were also instructed to complete and return the response form.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed nationwide to AR, FL, IA, IN, KY, NY, OK, TX, UT, VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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