FDA Medical Device Recalls (openFDA)
MMS Sales Corp: Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.
- Recall number
- Z-0764-05
- Recalling firm
- MMS Sales Corp
- Product
- Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.
- Status
- Terminated
- Initiated
- 2005-02-21
- Posted
- 2005-04-27
- Terminated
- 2006-12-20
- Reason
- Partial occlusion in the T-piece resulting in airway obstruction.
- Root cause
- Other
- Action
- The firm initiated the recall on February 21, 2004 by letter to all consignees.
- Quantity
- Total for all products: 7455 cases (161,273 units)
- Distribution
- Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
- Lot, serial or model codes
- Part Number 384001, 20 per case, Lot numbers: 551880804, 581451104, 581461104; Part Number 386000, 15 per case, Lot numbers: 551890804, 600080205, 5518908004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAI
- Firm FEI
- 3004752896
- Firm city
- Pharr
- Firm state
- TX
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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