Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
FDA device recall Z-1100-2023 · posted 2023-02-07 · Open, Classified
Recall details
- Recalling firm
- Quest Medical, Inc.
- Reason for recall
- Delivery Sets may have tubing that could become detached that could result in patient infection.
- Action taken
- On 12/23/22, the recall notice was distributed. The customer was asked to return affected devices and to call 1-800-627-0226, extension 311, if they had any questions.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FPA
- Quantity affected
- 13,900
- Distribution
- US Nationwide distribution in the state of MA.
- Date initiated
- 2022-12-23
- Date posted
- 2023-02-07
- Location
- Allen, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Precision Delivery Infusion Set (K202672) | Quest Medical, Inc. | 2021-01-21 |