The Recall Desk
HighFDA (Devices)·Z-0180-2020·Announced 2019-10-30

Andover Healthcare Recalls Sterile Co-Flex NL Wound Dressings Due to Packaging Defect

Andover Healthcare Inc. is recalling 8,500 cases of sterile Co-Flex NL 4-inch wound dressings because of incomplete packaging seals that may compromise sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile medical device with a defect that compromises sterility, creating a risk of infection (high-risk hazard) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Andover Healthcare Inc. is recalling 8,500 cases of Sterile Co-Flex NL 4-inch single-use secondary wound dressings or compression wraps. The recall is due to incomplete packaging seals on the sterile product, which may compromise the sterility of the device.

The affected products were distributed nationwide in the United States, including in Massachusetts, Texas, Rhode Island, Ohio, New York, Minnesota, South Dakota, Illinois, Missouri, Florida, Virginia, Nebraska, Utah, and California. The recall includes products with Catalog # 5400S and expiration dates ranging from October 1, 2021, to June 14, 2022. Specific lot numbers involved are CI0PVV, CI0V78, CI0X0B, CI16CG, CI17BB, CI18KB, CI18Y7, CI1E36, and CI1JCE.

Consumers and healthcare facilities should stop using the affected products and contact Andover Healthcare Inc. for further instructions or a refund.

The recalled product

Product
Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap
Manufacturer
Andover Healthcare Inc.
Category
Medical Device — Wound Dressing
Hazard
Affected units
8,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • CI0V78
  • CI0X0B
  • CI16CG
  • CI17BB
  • CI18KB
  • CI18Y7
  • CI1E36
  • CI1JCE

Distribution

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Andover Healthcare Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Andover Healthcare Inc.

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Same hazard · sterility compromise

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