TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is inten
FDA device recall Z-0889-2011 · posted 2011-01-10 · Terminated
Recall details
- Recalling firm
- Cardiac Assist, Inc
- Reason for recall
- Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications
- Action taken
- CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 164
- Distribution
- Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
- Date initiated
- 2010-12-02
- Date posted
- 2011-01-10
- Date terminated
- 2011-12-01
- Location
- Pittsburgh, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 (K052570) | Cardiacassist, Inc. | 2006-01-17 |