Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0764-05

Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001...

MMS Sales Corp / initiated 2005-02-21 / Terminated

MMS Sales Corp began a recall of Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made... on . The reason FDA records is "Partial occlusion in the T-piece resulting in airway obstruction". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0764-05
Status
Terminated
Initiated
Posted
Terminated
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.
Product code
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
Reason for recall
Partial occlusion in the T-piece resulting in airway obstruction.
FDA root cause
Other
Action
The firm initiated the recall on February 21, 2004 by letter to all consignees.
Quantity in commerce
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
Product codes and lots
Part Number 384001, 20 per case, Lot numbers: 551880804, 581451104, 581461104;  Part Number 386000, 15 per case, Lot numbers: 551890804, 600080205, 5518908004