Custom inflation kits recalled over inflation handles that may detach
Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit 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 Merit Medical Custom Inflation Kit is being recalled by Merit Medical Systems, Inc., covering reference numbers K05-00761F, K05-01717B, K05-02080D, K05-02090C, K05-02221, K05-02338, K05-02470, K05-02954, K05-03094A, K05T-00380C, K05T-01674B, K05T-01863, K05T-01915, K05T-01920F, K05T-01955, K05T-02138, K05T-02138A and K05T-02272G, with further reference numbers listed in the enforcement record.
The reason given in the enforcement record is that the inflation device handle may detach from the syringe during a procedure.
The record lists 18,897 units, with UDI and 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 kits and follow Merit Medical's instructions.
The recalled product
- Product
- Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Procedure kit
- Affected units
- 18,897
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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