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Coflex TLC
Andover Healthcare, Inc. · Model XL REG TN/LB 4" · UDI-DI 10724004611303
2
510(k) clearances
70
Adverse events (5 deaths)
6
Recalls
239
Facilities
Description
Two-Layer Compression Kit Layer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. XL REG TN/LB 4"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-02 | Safeguard US Operating LLC | Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of s |
| 2016-02-24 | Amd Ritmed | Product does not meet sterility requirements based on FDA analysis and tested positive for Bacterium Bacillus. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
| 2006-08-16 | International Medsurg Connection, Inc. | The bandages labeled as sterile had not been sterilized prior to distribution. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.