Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01
FDA Recall Z-2154-2010 · Posted 2010-08-02
Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDTR
Date Initiated2010-06-08
Date Terminated2012-05-07
Product Quantity4 packs
Reason for Recall
Vent port may be occluded and prevent delivery of fluid
Firm Action
Terumo, Ashland, MA notified consignees on 6/8/10, by
phone, fax, email and mail to advise distributors and end-users of the required recall actions. Follow-up communication sent by priority overnight
mail on 6/9/10, with proof of delivery, specifying the awareness to the issue and necessary correction
activities should a unit be discovered. Phase 2 initiated on 7/1/10 to sale rep to remove recalled product and perform a product reconciliation to ensure that all affected product is identified, returned to Terumo CVS, and that replacement product is sent immediately.
Root Cause
Equipment maintenance
Distribution Pattern
Distribution USA and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.