Recall Weekly
Moderate riskFDA DeviceClass II

Halyard Major Pack surgical kit recalled for incomplete header bag seal

AVID Medical is recalling Halyard Major Pack surgical kits (Catalog Number JEMJ10-01) because the header bag seal may not close completely. This affects 90 units distributed to 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. Check if you have Halyard Major Pack (Catalog JEMJ10-01, Lot 1635770, expiration 7/26/2027)
  2. Do not use affected kits
  3. Contact your supplier or AVID Medical for instructions on return or replacement
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
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
90 units
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class II
Recall number
Z-0929-2026

In the FDA's words

Description
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. Potential for incomplete seal on header bag. Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027. Distribution: US distribution to GA, IL, NE, MD. Affected quantity: 90 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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