—#166993

Product

Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

FDA product code: NAD — Dressing, Wound, Occlusive
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K990530
Affected lot / code info: Lot Numbers: 18D180662,18E070362,18E222362,18F072362

Why it was recalled

Potential for product sterility breach due to a compromised or pinched seal defect

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

On August 1, 2018 Cardinal Health issued Urgent Medical Device Recall notices to U.S. customers via Fed Ex and OUS customers were directly contacted by Quality & Regulatory Affair representatives supporting that country. Customers were advised to take the following actions: 1. Inspect stock and quarantine affected product. 2. Immediately stop using affected product. 3. Return the completed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from customers, and to prevent further notices. 4. Notify any customers to whom you may have distributed product affected by this recall. 5. Contact the appropriate Customer Service group to arrange for credit and return of any affected product you may have: Hospital 800-964-5227 Federal Government 800-444-1166 Distributors800-635-6021 All other customers 888-444-5440 Customers with any questions regarding this letter may call (800) 292-9332.

Recalling firm

Firm: COVIDIEN LLC
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2018-08-01
Terminated: 2020-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.