Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Reported: October 10, 2018 Initiated: August 1, 2018 #Z-0013-2019
Product Description
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
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? ▼
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.. 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-0013-2019.
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