Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
FDA device recall Z-2346-2015 · posted 2015-08-05 · Terminated
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
- Action taken
- Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GBZ
- Quantity affected
- 62 cases (10/cs)=620 units
- Distribution
- AZ, CA, LA. IN, NC, TN, TX, VA
- Date initiated
- 2015-06-19
- Date posted
- 2015-08-05
- Date terminated
- 2016-03-21
- Location
- Hudson, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATRIUM THORACIC CATHETER (K831931) | Atrium Medical Corp. | 1983-10-04 |