FDA Medical Device Recalls (openFDA)
Applied Medical Resources Corp: Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
- Recall number
- Z-0023-2009
- Recalling firm
- Applied Medical Resources Corp
- Product
- Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
- Status
- Terminated
- Initiated
- 2008-06-25
- Posted
- 2008-10-07
- Terminated
- 2012-03-26
- Reason
- 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).
- Root cause
- Process control
- Action
- 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.
- Quantity
- 14,113 total
- Distribution
- Nationwide and Canada distribution.
- Lot, serial or model codes
- Product/Kit Batch Numbers: 1061480, 1061127, 1060184, 1058796, 1058108, 1056578, 1056709, 1054094, 1054837
- 510(k) numbers
- ["K012884","K945741"]
- PMA numbers
- not on file
- Product code
- HET
- Firm FEI
- 2027111
- Firm city
- Rancho Santa Margarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28