Surgical instrument kits recalled for loose metal flakes
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
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: FDA Class II medical device with potential for patient harm through metal contamination in surgical sites. The source indicates loose metal flakes may detach and cause local or foreign body reactions, but no reported illnesses or injuries have occurred. Per the rubric, risk-of-harm medical device products without reported injury are scored High.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard CPT EP PACK surgical convenience kits (Model SHAN442-04, Lot 1608261) distributed nationwide. The kits contain sponge forceps and towel clamps with small loose metal flakes that may detach.
Metal flakes that detach from these instruments could enter a patient's surgical site undetected. Once present, they may cause local reactions or foreign body reactions.
Patients who received these kits or had procedures using these instruments should contact their healthcare provider if they experience unexpected complications. Healthcare facilities should discontinue use and return affected kits to AVID Medical.
The recalled product
- Product
- Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-contamination
- foreign-body-injury
- local-tissue-reaction
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 (1)
- GTIN: 10809160413470 Lot Number: 1608261
Distribution
Distributed nationwide across the United States.
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