Angioplasty packs recalled over inflation handles that may detach
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.
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: Scored 3 under the risk-of-harm criterion: the firm states the inflation device handle may detach during a procedure, and no injuries are reported.
Plain-English summary
The Allwell Angioplasty Pack, REF IS-30-B1/B is being recalled by Merit Medical Systems, Inc.
The reason given in the enforcement record is that the inflation device handle may detach from the syringe during a procedure.
The record lists 328,000 units under UDI 00884450653388, with lot numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across a wide range of states. The FDA has classified the action as Class II.
A device component that detaches mid-procedure can interrupt the procedure. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Merit Medical's instructions.
The recalled product
- Product
- Allwell Angioplasty Pack REF: IS-30-B1/B
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 328,000
Distribution
Part of a larger recall action
This product is one of 7 recalled by Merit Medical Systems, 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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