Recall Z-0708-2017 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Inc. (Navilyst Medical Inc.)
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampl
| Date | Aug 29, 2016 |
| Status | Terminated |
| Reason | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits. |
| Root cause | Under Investigation by firm |
| Action | Navilyst sent an Urgent Voluntary Medical Device Recall notices, reply forms and a copy of Medline's Recall Notice to the their customers. The letter identified the product, the problem, and the action to be taken by the customer. Navilyst Medical, Inc. (an AngioDynamics Company), the manufacturer of the Xcela" PICC w/PASV, the BioFlo PICC w/ Endexo, and the BioFlo PICC w/ Endexo and PASV is conducting a medical device recall based on information received from Medline. Medline has determined that the sterile gloves listed in their Recall Notification dated August 3, 2016 may contain an |
| Quantity | 75 packages (boxes of 5) |
| Distribution | Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142616 | PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc., Oct 14, 2014 |