ClearanceBrief
Recall Z-0765-05 ยท CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

MMS Sales Corp

Circuit- Matching Kit, 40'' Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Manufactured for Pall Life Sciences, Ann Arbor, Michigan. Made in Mexico.

DateApr 27, 2005 (initiated Feb 21, 2005)
StatusTerminated
ReasonPartial occlusion in the T-piece resulting in airway obstruction.
Root causeOther
ActionThe firm initiated the recall on February 21, 2004 by letter to all consignees.
QuantityTotal for all products: 7455 cases (161,273 units)
DistributionProduct 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.