Bard Access Systems Inc.: Medical Device Recall in 2021 - (Recall #: Z-1658-2021)
See the recall detail below. You can also see other recalls from the same firm in 2021.
REF 7812400, Replacement Connector For 4F Groshong NXT clearVue PICC with Extension Leg, Rx Only, Sterile EO, CE 2797, UDI: (01)10801741075268 - Product Usage: is designed for use when central venous catheterization is prescribed.
Class II
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Lot No. redr1671 reds4453 redt1612 redt2758 redt3914 redu0326 redu3286 redu3402 redu4194 redu4226 redv1248 redv2001 redv2750 redw0124 redx3813 redx3828 redy1863 redy2874 redy3867 redz0552 redz1927 redz3505 REEN1390 reen1396 reeq1509 reet2730 reet3239 reeu0563 reew2029 reex2346 reex3092 reey2704 reex3917
Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
Voluntary: Firm initiated