Recall Weekly
Moderate riskFDA DeviceClass II

Halyard EP LAB PK sterile field pack recalled for incomplete header bag seal

AVID Medical is recalling Halyard EP LAB PK sterile field packs (Catalog Number ESJH009-03) because the header bag may not seal completely during sterilization. An incomplete seal could allow bacteria or other contaminants to enter the sterile package before use. This affects 240 units distributed to hospitals and medical facilities in Georgia, Illinois, Nebraska, and Maryland.

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

What to do

  1. Stop using affected Halyard EP LAB PK packs immediately, especially Lot 1653112
  2. Check your inventory for Catalog Number ESJH009-03 and UDI-DI 10809160427316
  3. Contact AVID Medical or your supplier for instructions on safe disposal and replacement
  4. Review any procedures already performed with packs from this lot
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
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
240 units
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, VA, United States
Classification
Class II
Recall number
Z-0927-2026

In the FDA's words

Description
Halyard, EP LAB PK. Catalog Number: ESJH009-03. Potential for incomplete seal on header bag. Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028. Distribution: US distribution to GA, IL, NE, MD. Affected quantity: 240 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