Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Manufacturer: Medtronic, Inc. Minneapolis, MN 55432-5604 USA. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag seves as the product sterile barrier.
FDA Recall Z-1227-2007 · Posted 2007-09-25
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Recalling FirmMedtronic Perfusion Systems
Recall StatusTerminated
Product CodeDWE
Date Initiated2007-08-01
Date Terminated2008-10-10
Product Quantity853 packs
Reason for Recall
Medtronic Custom Tubing Packs might have open header bag seals.
Firm Action
Certified letters dated 8/1/07 were sent to customers. The letter explains the situation and requests the impacted product to be returned to Medtronic for replacement or credit. The customers are being requested to complete a Recall Certificate acknowledging the receipt of the information.
Root Cause
Other
Distribution Pattern
Nationwide.
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.
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