Recall Z-0352-2020 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Smiths Medical ASD Inc.
ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
| Date | Nov 26, 2018 |
| Status | Terminated |
| Reason | Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard. |
| Root cause | Equipment maintenance |
| Action | On about November 26, 2018, Smiths Medical sent an URGENT MEDICAL DEVICE RECALL NOTICE via email or FedEx, (where email addresses are not available) and accompanying Recall Response Forms to all consignees who purchased potentially affected product. Consignees with potentially affected product were instructed to immediately segregate the product and return them to Stericycle, via pre-paid shipping label. They we also instructed to notify customers if the affected product was further distributed and complete and return the Recall Response Form. Questions can be submitted to Smith Medical vi |
| Quantity | 219,150 devices |
| Distribution | United States - AK, AZ, FL, GA, IL, IN, KS, LA, MD, MN, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. One foeign consignee in Costa Rica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990236 | MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT Johnson & Johnson Medical, Div. of Ethicon, Inc., Aug 20, 1999 |