Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 500
FDA device recall Z-0361-2016 · posted 2015-12-02 · Terminated
Recall details
- Recalling firm
- Quest Medical, Inc.
- Reason for recall
- The products have been found to intermittently exhibit a seal failure during use.
- Action taken
- The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- DTR
- Quantity affected
- 18,761 units
- Distribution
- Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
- Date initiated
- 2015-10-28
- Date posted
- 2015-12-02
- Date terminated
- 2016-11-17
- Location
- Allen, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MYOCARDIAL PROTECTION SYSTEM (K953838) | Quest Medical, Inc. | 1996-03-06 |