Recall Z-1551-2009
Medtronic Cardiovascular Revascularization & Surgical Therap · initiated March 23, 2009
Product
Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System
Codes / lots: Lot Numbers: 0000567714, 0000569193, 0000569453, 0000571627, 0000574238, 0000579154, 0000579157 and 0000580322.
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
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1551-2009
- Initiated
- March 23, 2009
- Posted by FDA
- July 13, 2009
- Terminated
- May 22, 2012
- Product code
- OEU – Cardiopulmonary Bypass Catheter Kit
- Quantity
- 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.
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1550-2009 | Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00…Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use… | 03/23/2009Terminated |
| Z-1552-2009 | Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R…Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use… | 03/23/2009Terminated |