Interventional radiology packs recalled over open header bag seals compromising sterility
Halyard CPT Basic IR Packs, model 1646381, are recalled because of the potential for open header bag seals, compromising sterility. 228 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; compromised sterility on a procedure pack is a potential harm and no injuries are reported.
Plain-English summary
The Halyard CPT Basic IR Pack, model number 1646381, UDI 10809160363256, is being recalled. The affected product is lot 1646381 with an expiration date of 1/31/2028. The recall covers 228 units distributed in Florida.
The recall was issued because of the potential for open header bag seals, compromising the sterility of the convenience kit. The FDA classified the action as Class II.
Hospitals and interventional radiology units holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Procedure Kits
- Affected units
- 228
Distribution
Part of a larger recall action
This product is one of 2 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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