Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Se
FDA device recall Z-0023-2009 · posted 2008-10-07 · Terminated
Recall details
- Recalling firm
- Applied Medical Resources Corp
- Reason for recall
- Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02).
- Action taken
- Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 14,113 total
- Distribution
- Nationwide and Canada distribution.
- Date initiated
- 2008-06-25
- Date posted
- 2008-10-07
- Date terminated
- 2012-03-26
- Location
- Rancho Santa Margarita, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DILATING TIP OBTURATOR (K012884) | Applied Medical Resources Corp. | 2002-01-17 |
| TROCAR AND CANNULA ACCESSORY (K945741) | Applied Medical Resources | 1995-02-28 |