Z-0018-2019Class II
Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106
Medtronic, Inc. / initiated 2018-08-01 / Terminated / root cause: manufacturing process
COVIDIEN LLC began a recall of Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads... on . FDA classified it as Class II and gives the reason as "Potential for product sterility breach due to a compromised or pinched seal defect". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0018-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medtronic, Inc.
- Product
- Dermacea Gauze Fluff Roll, 6 Ply, 4 x 4-1/8 yd (10.2 cm x 3.7 m), REF 441106 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
- Product code
- NAD Dressing, Wound, Occlusive
- Reason for recall
- Potential for product sterility breach due to a compromised or pinched seal defect
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity in commerce
- 2,730,821 units in total
- Distribution
- US Nationwide Distribution
- Product codes and lots
- Lot Numbers: 18D180762,18D180862,18E029062,18E029162,18E029262, 18E029362,18E070662,18E070462,18E070562,18E130962, 18E131062,18E166462,18E166562,18E131162,18E222562, 18E222462,18F034562,18F034462,18F034362,18F072562, 18F072462,18F122462,18F122362
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0013-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0014-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0015-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0016-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0017-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0018-2019 | Class II | Terminated | Voluntary: Firm initiated |
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