Device Recall Vaxcel PICC with PASV IR145 Kit

Batch/Lots: 1) 4748893, 4766101, 4773293 & 4814220 with Use By Range 2016-05-31 to 2016-10-31.  Batch/Lots: 2) 4752348, 4784466, 4735032, 4738833, 4765395 & 4814222 with Use By Range 2016-05-31 to 2016-07-31.  Batch/Lots: 3) 4752881, 4765393 & 4942171 with Use By Range 2016-05-31 to 2017-09-30.

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.

Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.