AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN
FDA device recall Z-2193-2008 · posted 2008-09-03 · Terminated
Recall details
- Recalling firm
- AGA Medical Corporation
- Reason for recall
- AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility. AGA is asking that customers inspect the specific lot of devices to confirm the integrity of the ou
- Action taken
- The firm Fed Ex'd and emailed a Field Inspection/Correction letter to customer 04/28/2008. The letter identified affected product, requested that customers check the outer package seal, and if it is incomplete the device should be returned for replacement. A form was also asked to be returned to AGA Medical. Contact AGA Medical at 1-763-513-9227 for assistance.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- MJN
- Quantity affected
- 131 (34 US, 97 OUS)
- Distribution
- Within the US to include: AL, AZ, CA, CT, FL, IA, ID, MA, MD,MI, MO, NC, NH, NY, OH, PA, SD, TN, TX, WI. OUS to include: Brazil, Greece, Netherlands, Portugal, and Slovakia
- Date initiated
- 2008-04-25
- Date posted
- 2008-09-03
- Date terminated
- 2010-10-13
- Location
- Golden Valley, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMPLATZER SIZING BALLOON II (K053440) | Aga Medical Corp. | 2005-12-30 |