Andover Healthcare Inc.: Incomplete packaging seal of sterile product

Agency Publication Date: October 23, 2019

Affected Products

Product: Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

Manufacturer's product or Catalog # 5300S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0ST7, CI0ZJT, CI17BA, CI18Y6, CI1HM0

Lot Numbers:

CI0ST7

Product: Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 5400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE

Lot Numbers:

CI0PVV

Product: Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 9300S Expiration Date: 01OCT2021-14JUN2022 LOT # CIOZJV, CI02SW, CI18YA, CI1FJ2

Lot Numbers:

CIOZJV

Product: Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF

Lot Numbers:

CI147V

Product: Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 7300S Expiration Date: 01OCT2021-14JUN2022 Lot : CI10LN

Lot Numbers:

CI10LN

Product: Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 7400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0X0D, CI18K8, CI1DXN

Lot Numbers:

CI0X0D

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83239

Status: Resolved

Manufacturer: Andover Healthcare Inc.

Manufactured In: United States

Units Affected: 6 products (1798 Cases; 8500 Cases; 330 Cases; 1759 Cases; 269 Cases; 1050 Cases)

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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.

Affected Products

Product: Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap.

Manufacturer's product or Catalog # 5300S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0ST7, CI0ZJT, CI17BA, CI18Y6, CI1HM0

Lot Numbers:

CI0ST7

Product: Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 5400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, CI1JCE

Lot Numbers:

CI0PVV

Product: Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 9300S Expiration Date: 01OCT2021-14JUN2022 LOT # CIOZJV, CI02SW, CI18YA, CI1FJ2

Lot Numbers:

CIOZJV

Product: Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 9400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI147V, CI15F1, CI17B9, CI18Y0, CI1FJ3, CI1JCF

Lot Numbers:

CI147V

Product: Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 7300S Expiration Date: 01OCT2021-14JUN2022 Lot : CI10LN

Lot Numbers:

CI10LN

Product: Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap

Manufacturer's product or Catalog # 7400S Expiration Date: 01OCT2021-14JUN2022 Lot # CI0X0D, CI18K8, CI1DXN

Lot Numbers:

CI0X0D