L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Recall
- Recall Number
- Z-2638-2024
- Event Number
- 94951
- Firm
- Argon Medical Devices, Inc
- FEI Number
- 1625425
- Product Code
- LJS
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- June 14, 2024
- Posted
- August 16, 2024
- Address
- 1445 Flat Creek Rd, Athens, TX, 75751-5002
Description
L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
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.
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 with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred or further distributed. 5) Complete and return the response form via email to [email protected] If you need assistance in returning the units, please contact [email protected]. If you have any questions about this letter, please contact [email protected] or [email protected].
US distribution to the states of: TX, WA, CA, IL
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