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Terminated

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

FDA Recall Z-1367-2019 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeMQH
Date Initiated2019-03-27
Date Terminated2020-05-01
Product Quantity480 units

Reason for Recall

ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent

Firm Action

CooperSurgical issued recall letter dated March 27, 2019 identified problem and action to take: discontinue use of this discrepant product, quarantine the product, and complete the Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Contact: 203-601-5200 ext. 3300.

Root Cause

Under Investigation by firm

Distribution Pattern

Foreign: Denmark, Italy, Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K990847INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING MHumagen Fertility Diagnostics, Inc. · 1999-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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