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.
Reported: October 10, 2018 Initiated: August 1, 2018 #Z-0017-2019
Product Description
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.
Reason for Recall
Potential for product sterility breach due to a compromised or pinched seal defect
Details
- Recalling Firm
- COVIDIEN LLC
- Units Affected
- 2,730,821 units in total
- Distribution
- US Nationwide Distribution
- Location
- Mansfield, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by COVIDIEN LLC. Units affected: 2,730,821 units in total.
Why was this product recalled? ▼
Potential for product sterility breach due to a compromised or pinched seal defect
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 10, 2018. Severity: Moderate. Recall number: Z-0017-2019.
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