Recall Z-0190-2020 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Smiths Medical ASD Inc.
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8
| Date | Jul 8, 2019 |
| Status | Terminated |
| Reason | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. |
| Root cause | Process control |
| Action | Smiths Medical notified customers during the week of 07/08/2019 via "URGENT MEDICAL DEVICE RECALL NOTICE" letter. The Recall Notice advised customers that Smiths Medical has initiated a voluntary field removal for specific lots of GRIPPER needles and specific lots of PORT-A-CATH Trays containing GRIPPER needles. Customers were instructed to examine inventory for affected product and complete and return the Response Form to GRIPPERocclusion2019@smiths-medical.com. Once the response form is received, Customer Service will provide a shipping label to return all affected product to Stericycle |
| Quantity | 3,952,509 devices total |
| Distribution | Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR. International distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS Smiths Medical MD, Inc., Dec 14, 2007 |