Recall Z-1367-2019— CooperSurgical, Inc.

Name: FDA recall Z-1367-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-27

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2019-03-27, terminated 2020-05-01. It names one FDA 510(k) clearance: K990847. Product: ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0. Reason: ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent.

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-27
Terminated: 2020-05-01
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K990847 — INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING MHumagen Fertility Diagnostics, Inc.·cleared 1999-07-14

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

ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0

Reason for recall

ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

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