Halyard Urology Laparotomy Pack surgical instruments recalled for detachable metal flakes
AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving a risk of metal fragment contamination in surgical sites. No illnesses or injuries have been reported in the source material. The hazard presents a serious potential for harm, qualifying as a high-risk product where injury has not yet been reported.
Plain-English summary
AVID Medical is recalling the Halyard Urology Laparotomy Pack (Model SAMM023-13, Lot Number 1595070), a sterile surgical instrument kit containing sponge forceps and towel clamps.
The sponge forceps and towel clamps are associated with loose metal flakes that may detach from these components. If metal flakes enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions.
The affected product was distributed nationwide throughout the United States. Patients and healthcare providers who have received this lot should stop using it and contact AVID Medical for instructions regarding return or replacement.
The recalled product
- Product
- Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 14
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: 10809160382172 Lot Number: 1595070
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 recalled by AVID Medical, 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.
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