—#68352

Product

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)

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K982891
Affected lot / code info: Lot Numbers: GF08, GF30, GN06, HA15, HE09, HH02, HK27, HM01, HM22, HN12, HP17 and KA07.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corp
Address: 6200 Jackson Rd, Ann Arbor, Michigan 48103-9586

Distribution

Distribution pattern: Nationwide-USA including states of Missouri, Tennessee and Wisconsin-Custom Kits for 3 hospitals.

Timeline

Recall initiated: 2008-01-29
Posted by FDA: 2008-03-28
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68352. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.