Recall Weekly
Moderate riskFDA DeviceClass II

Halyard General Laparoscopy Pack recalled for incomplete header bag seal

Halyard's General Laparoscopy Pack (catalog number VAST018-10) may have an incomplete seal on its header bag, which could compromise the sterility of the surgical instruments inside. This affects 42 units distributed to hospitals and surgical centers in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All AVID Medical recalls

What to do

  1. Stop using affected units immediately (lot 1651776, expiration 3/12/2027)
  2. Check your inventory for catalog number VAST018-10 and lot number 1651776
  3. Contact your distributor or Halyard/AVID Medical for return or replacement instructions
  4. Review your surgical records to identify any patients who may have received instruments from affected packs
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Sold in
US distribution to GA, IL, NE, MD.
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
42 units
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class II
Recall number
Z-0926-2026

In the FDA's words

Description
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10. Potential for incomplete seal on header bag. Catalog Number: VAST018-10. UDI-DI: 10809160452257. Lot Number: 1651776. Expiration Date: 3/12/2027 Distribution: US distribution to GA, IL, NE, MD. Affected quantity: 42 units
Hazard
Potential for incomplete seal on header bag.

5 products in this recall

Halyard surgical packs recalled for incomplete packaging seal

AVID Medical is recalling five Halyard procedure packs because the header bag may not be fully sealed. The recall includes 728 units distributed in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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Related topics

SterilityMedical devicesGAILMDNEMore from FDA Device