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Terminated

Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047

FDA Recall Z-0005-05 · Posted 2004-10-05

Recalling FirmCooperSurgical, Inc.
Recall StatusTerminated
Product CodeHDB
Date Initiated2004-08-17
Date Terminated2012-05-10
Product Quantity495 units

Reason for Recall

Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System

Firm Action

CooperSurgical telephoned consignees on 8/18/04 and sales representatives to visit the account for removal of recalled product.

Root Cause

Other

Distribution Pattern

FL, IA, KS, GA, MA, MN, MS, NE, NY, OH, OK, VA, ME, TX, VA Foreign: Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011532MITYVACPrism Enterprises, Inc. · 2001-07-30

Official Source

View FDA Recall →

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

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