Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catalog No. 804113)
- Recall Initiated
- January 29, 2008
- Posted
- March 28, 2008
- Terminated
- July 7, 2009
- Recall Number
- Z-1311-2008
- Quantity
- 110
- Firm Location
- Ann Arbor, MI
Reason for Recall
Loose Flash at tip of Weighted Flexible Sucker: A loose strand of stainless steel left on the device during manufacturing by an outside supplier may result in an unretrieved metal fragment remaining in the patient.
Distribution
Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.
Lot / Code Info
Lot Numbers: GF08, GF30, GN06, HA15, HE09, HH02, HK27, HM01, HM22, HN12, HP17 and KA07.
Root Cause
Nonconforming Material/Component
Action Taken
Consignees were notified via recall letter, Urgent Medical Device Removal, dated 1/29/08 via fax or email to cease using the weighted sucker in the packs and to use an alternative sucker until replacement product arrives from Terumo.
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