Merit Medical Systems, Inc.: Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

Is my product affected?

Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # K14-00079

• UPC 00884450328620

Check against the official notice below — it lists the full affected range.

What happened

Merit Medical Systems, Inc. recalled 44 Custom Dialysis Kit CF-4235 Without Gel units that were distributed in the United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom. The kits contained Flex-Neck Classic Peritoneal Dialysis Catheters with 2 cuffs that were incorrectly configured and labeled as 1 cuff products. The affected products came from two lots: Lot #H1190448 (expiration 7/31/2020) and Lot #H1193585 (expiration 5/30/2019).

The recall notice does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits.

Details from the source

Reason for recall: 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits. Distribution: United States, Austria, Finland, Germany, Ireland, Switzerland, and United Kingdom Quantity: 44 Lot/code info: Lot #: a) H1190448, Exp 7/31/2020, UDI (01)00884450328620(17)200731(10)H1190448; b) H1193585, Exp 5/30/2019, UDI (01)00884450328620(17)190530(10)H1193585

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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