Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for
FDA device recall Z-1700-2015 · posted 2015-06-02 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- The product failed to meet the internal established statistical test requirement for heparin activity.
- Action taken
- On 05/05/2015 Edwards sent their consignees a letter including the following instructions: Once you have verified your inventory, please complete the attached acknowledgement form (even if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for an RGA prior to returning any unused product and return unused product to the following address: Edwards Lifesciences Return Goods/RGA # XXXXXX 1212 Alton Pkwy., Irvine, CA 92606-4838
- Root cause
- Process control
- Status
- Terminated
- Product code
- DYG
- Quantity affected
- 978
- Distribution
- Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
- Date initiated
- 2015-05-05
- Date posted
- 2015-06-02
- Date terminated
- 2016-10-17
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (K940795) | Baxter Edwards | 1994-05-24 |