Recall Z-2089-2019— Wilson-Cook Medical Inc.

Name: FDA recall Z-2089-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-14

Class II · Terminated

Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2019-06-14, terminated 2021-04-02. It names one FDA 510(k) clearance: K941305. Product: Acuject Variable Injection Needle. Reason: Potential for occluded injection needles..

Recalling firm: Wilson-Cook Medical Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-14
Terminated: 2021-04-02
Firm location: Winston Salem, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K941305 — WILSON-COOK VARIABLE LENGTH GI INJECTION NEEDLEWilson-Cook Medical, Inc.·cleared 1994-06-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Acuject Variable Injection Needle

Reason for recall

Potential for occluded injection needles.

Data sourced from openFDA. This site is unofficial and independent of the FDA.