CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report
Halyard Laparotomy Gyn Pack - Medical convenience kits recalled
AVID Medical is recalling Halyard Laparotomy Gyn Pack - Medical convenience kits, distributed nationwide in the US. The recall was initiated on 20 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0423-2025
- FDA event ID
- 95515
- Recalling firm
- AVID Medical, Toano, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Sep 2024
- FDA classified
- 14 Nov 2024
- Reported
- 20 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 20 Sep 2024 | Recall initiated by company | |
| 14 Nov 2024 | Classified by FDA | +55 days |
| 20 Nov 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Halyard Laparotomy Gyn Pack - Medical convenience kits recalled?
Yes. AVID Medical recalled Halyard Laparotomy Gyn Pack - Medical convenience kits on 20 Sep 2024. The recall is Class II and its status is Ongoing. Recall number Z-0423-2025.
Why was it recalled?
Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Which lots are affected?
GTIN: 10809160410141 Lot Number: 1589639
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AVID Medical
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