510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1552-2009

Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R...

Medtronic Perfusion Systems / initiated 2009-03-23 / Terminated / root cause: packaging
FDA source (opens on fda.gov)

Medtronic Cardiovascular Revascularization & Surgical Therap began a recall of Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5... on . The reason FDA records is "Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not...". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1552-2009
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Perfusion Systems
Product
Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories.
Product code
OEU Cardiopulmonary Bypass Catheter Kit
Reason for recall
Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the com
Root cause tag
packaging
FDA root cause
Packaging process control
Action
An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product. For further questions, contact Medtronic at 1-763-514-9605.
Quantity in commerce
1363 kits total (1215 US, 148 OUS)
Distribution
Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
Product codes and lots
Lot Numbers: 0000570588, 0000574333, 0000597907, 0000597954, 0000603799, 0000603854, 0000604000, 0000604584, 0000604619, 0000607627, 0000611283, 0000617833, 0000624995, 0000628687, 0000641735, 0000644599, 0000645307, 0000648997, 0000653336, 0000654111, 000065606, 0000662898, 0000666630, 0000666650, 0000676750, 0000680771, 0000682337, 0000697089, 0000699592, 0000708267, 0000708363, 0000712299, 0000721526, 0000727448, 0000738389, 0000756494, 0000762708, 0000797022, 0000805167, 0000805376, 0000806225, 0000806808, 0000812913, 0000838110, 0000846202, 0000849687, 0000850497, 0000854152, 0000854999, 0000856172 and 0000969188.