Peripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk

Plain-English summary

Argon Medical Devices, Inc. is recalling certain L-Cath PICC S/L Peripherally Inserted Central Catheters. The affected devices are identified by REF numbers 384539, 384464, 384516, and 384463, with specific lot numbers and expiration dates listed in the FDA recall notice. The FDA has classified this as a Class II recall.

The catheters may leak and/or crack at the hub. According to the notice, this could lead to catheter replacement, inability to flush or aspirate the catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, and bloodstream infection.

The affected devices were distributed in the United States and internationally. The recall notice does not state that any injuries or deaths have occurred. The notice does not provide specific consumer instructions; patients who have this catheter should discuss the recall with their healthcare provider.

The recalled product

Product

L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463

Manufacturer

Argon Medical Devices, Inc

Category

Medical Device — Peripherally Inserted Central Catheter (PICC)

Hazard

• device-leak
• device-crack
• blood-loss
• infection

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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