Moderate riskFDA DeviceClass II

Halyard MINOR PACK kits recalled for potential open seals

AVID Medical, Inc. is recalling Halyard MINOR PACK kits, model VASF105-08, because the header bags may have open seals, which could compromise sterility. The notice covers 108 kits. No injuries have been reported.

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

What to do

  1. Set aside the affected kits and do not use them.
  2. Check for model VASF105-08, lot 1659384, UDI-DI 10809160451960, and expiration date 9/30/2027.
  3. The notice doesn't say how to get a replacement or refund; contact AVID Medical, Inc. for instructions.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
108 kits
Illnesses reported
None reported
Manufactured in
9000 Westmont Dr, Toano, Virginia, United States
Classification
Class II
Recall number
Z-0331-2027

In the FDA's words

Description
Halyard MINOR PACK. Model/Catalog Number: VASF105-08. Potential for open seals on header bags, compromising sterility. Model/Catalog Number: VASF105-08. UDI-DI: 10809160451960. Lot Number: 1659384. Expiration Date: 9/30/2027. Distribution: U.S Nationwide distributor in the state of Illinois. Affected quantity: 108 kits
Hazard
Potential for open seals on header bags, compromising sterility.

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