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| Ethicon is recalling lots of its Surgiflo hemostatic kits--courtesy of Ethicon |
Johnson & Johnson ($JNJ) unit Ethicon is recalling its some of Surgiflo hemostatic kits, warning that a packing issue could lead to breaches in the product, and the FDA has assigned its most serious label to the recall.
Surgiflo is a topical, absorbable hemostat used to stop bleeding in surgical procedures. Ethicon became aware of the packing problem back in the spring and is urging customers to return the affected lots once they're identified. The FDA has branded the affair a Class I recall, saying the recalled products could be rendered non-sterile and their use could to lead to serious injury or death.
Ethicon says it is yet to receive any reports of adverse events from Surgiflo, but the FDA is asking customers to report any problems through its online MedWatch system.
Ethicon has a long history of regulatory dustups, including the costly and deadly vaginal mesh debacle and an October Class I over malfunctioning surgical staplers. However, the company last week won FDA approval for its Evarrest Fibrin Sealant Patch, and J&J has committed to spending $185 million to expand Ethicon's suture-making plant in Athens, GA.
- here's the FDA's notice
- read Ethicon's letter (pdf)