Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weighted flexible sucker, Catalog No.: 804113)
This recall has been terminated (originally issued March 28, 2008).
- Recall Initiated
- January 29, 2008
- Posted
- March 28, 2008
- Terminated
- July 7, 2009
- Recall Number
- Z-1310-2008
- Quantity
- 739
- Firm Location
- Ann Arbor, MI
- Official Source
- View on FDA website ↗
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: GC06, GC27, GD27, GG19, GK07, GL05, GM02, GM30, HA02, HC05, HD12, HE23, HF29, HH23, HK27, HM22, HP03 and KA14.
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.