Recall Z-2886-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is intended to help provide protection against catheterrelated infections. The catheter is not intended to be used as a treatment
| Date | Jul 3, 2018 |
| Status | Terminated |
| Reason | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter. However, this product is incorrectly labeled as AK-25502, so the lidstock says it contains a 2-lumen, 5 Fr x 8 cm catheter. No patient injuries have been reported related to this issue. |
| Root cause | Employee error |
| Action | On July 3, 2018, the firm sent out Urgent Medical Device Recall letters to customers. The letter communicated the labeling error. Affected consignees are instructed to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above, so that the affected products can be returned to Arrow. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of produ |
| Quantity | 166 |
| Distribution | Distributors in MO and UT. Medical facilities in AL, CA, IL, MA, NH, NM, NY, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900263 | ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER Arrow Intl., Inc., Jul 24, 1990 |