VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by prope
FDA device recall Z-2091-2017 · posted 2017-04-25 · Terminated
Recall details
- Recalling firm
- Vortran Medical Technology 1, Inc
- Reason for recall
- Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.
- Action taken
- Medical Device Recall letters were sent on April 20, 2017. Letters explained the reason for recall and listed the specific lots sent to each distributor along with dates, PO numbers and quantity. Vortran Medical asks that each distributor provide a list of customers who received the affected product so that they can notify them directly of the recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 35 cases (10 each)
- Distribution
- CA, MS, FL
- Date initiated
- 2017-04-20
- Date posted
- 2017-04-25
- Date terminated
- 2017-10-17
- Location
- Sacramento, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM (K041473) | Vortran Medical Technology 1, Inc. | 2004-07-15 |
| RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (K001430) | Vortran Medical Technology 1, Inc. | 2000-07-05 |
| RESPIRTECHPRO (K973975) | Vortran Medical Technology 1, Inc. | 1998-06-12 |