Recall Z-2638-2024 · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Argon Medical Devices, Inc
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
| Date | Aug 16, 2024 (initiated Jun 14, 2024) |
| Status | Open, Classified |
| Reason | Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay. |
| Root cause | Employee error |
| Action | On 6/14/24,"URGENT PRODUCT RECALL NOTICE"s were emailed to Physicians, Clinicians, or Hospital Administrators describing the product, problem and the following actions to be taken. The customers were instructed to do the following: 1) Immediately discontinue use of the recalled device. 2) Segregate and quarantine the product subject to recall. 3) Return all affected devices to firm at Argon s expense, using RGA# 28348 to the following mailing address: RGA# 28348, Argon Medical Devices, Inc.,1445 Flat Creek Road Athens, TX 75751 USA, Attn: Arbee Cummings. 4) The recall notice should be shared |
| Quantity | 155 |
| Distribution | US distribution to the states of: TX, WA, CA, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters Argon Medical Devices, Nov 30, 2023 |