Halyard Laparotomy GYN Packs recalled due to loose metal flakes
AVID Medical recalls Halyard LAPAROTOMY GYN surgical packs due to loose metal flakes on sponge forceps and towel clamps. Metal fragments may enter the surgical site and cause local or 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 FDA Class II recall involves a risk-of-harm product (potential foreign body contamination in surgical instruments) with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported are rated as High (score 3).
Plain-English summary
AVID Medical, Inc. is recalling Halyard LAPAROTOMY GYN PACK surgical convenience kits (Model SAMM018-13, Lot 1589639) due to loose metal flakes on sponge forceps and towel clamps.
Sponge forceps and towel clamps in these kits may have small loose metal flakes on their components. These flakes could detach and enter a patient's surgical site undetected.
Metal flakes that enter the surgical site may cause local reactions or foreign body reactions. The affected kits were distributed nationwide across the United States.
Healthcare facilities and surgical professionals should discontinue use of the affected lot immediately. AVID Medical should be contacted for instructions on returning or replacing the kits. Providers should monitor patients who may have been treated with these instruments for any complications.
The recalled product
- Product
- Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 12
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: 10809160410141 Lot Number: 1589639
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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