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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: October 3, 2018
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Affected Products

Product: 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.

Lot Numbers: 18D180962,18D181062,18E029462,18E029562,18E070762, 18E131262,18E131362,18E131462,18E166662,18E167362, 18E223462,18E223362,18F054362,18E222662,18F034762, 18F034662,18F035562,18F072862,18F072662,18F072962, 18F123062,18F122562,18F122662

Lot Numbers:
Numbers
Product: Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Lot Numbers: 18D181262,18D181162,18E029662,18E029762,18E029862, 18E029962,18E030062,18E030162,18E030262,18E030362, 18E070962,18E071062,18E071162,18E071262,18E071362, 18E071462,18E071562,18E071662,18E131562,18E131962, 18E132062,18E132162,18E131662,18E131762,18E131862, 18E166762,18E167462,18E166862,18E166962,18E167562, 18E167162,18E167062,18E167762,18E167662,18E167262, 18E222762,18E223162,18E223062,18E222962,18E222862, 18E223662,18E223562,18E224062,18E223962,18E223862, 18E223762,18F035862,18F034962,18F034862,18F035262, 18F035162,18F035062,18F035362,18F035962,18F035762, 18F035462,18F089262,18F036262,18F036162,18F036062, 18F073062,18F072762,18F123262,18F123162,18F158462, 18F158362,18G004562

Lot Numbers:
Numbers
Product: Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Lot Numbers: 18E030462,18E223262,18F122962

Lot Numbers:
Numbers
Product: Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Lot Numbers: 18E071762,18E072262,18E072362,18E132262,18E132362

Lot Numbers:
Numbers
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.

Lot Numbers: 18D180662,18E070362,18E222362,18F072362

Lot Numbers:
Numbers
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.

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

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80924
Status: Resolved
Manufacturer: COVIDIEN LLC
Manufactured In: United States
Units Affected: 6 products (2,730,821 units in total)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.