Recall Z-2818-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.
| Date | Jul 10, 2018 |
| Status | Terminated |
| Reason | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. |
| Root cause | Under Investigation by firm |
| Action | The firm, Teleflex, sent an "Urgent Medical Device Recall Notification" letter dated 7/10/18 to customers. The letter included the following instructions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers 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 product you have on hand for return. |
| Quantity | 7024 units |
| Distribution | Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862056 | [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP Arrow Intl., Inc., Aug 25, 1986 |