Smiths Medical ASD Inc. recalls ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LU

Hazard / Issue

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Issued by

FDA

Distribution: Worldwide distribution.

Lot/Code Info: UDI/DI 30610586044179, Lot Numbers: 4010559AB, 4010560AB, 4010563AB, 4010573AB, 4016496AB, 4010561AB, 4010562AB, 4016490AB, 4010570AB, 4010569AB, 4016494AB, 4016497AB, 4010571AB, 4016491AB, 4010572AB, 4010574AB, 4016493AB, 4022630AB, 4025275AB, 4016492AB, 4016495AB, 4022621AB, 4022625AB, 4022628AB, 4006931AB, 4006933AB, 4006930AB, 4006932AB, 4022622AB, 4022623AB, 4022627AB, 4022624AB, 4022626AB, 4022632AB, 4022629AB, 4022631AB, 4025277AB, 4022633AB, 4022634AB, 4025274AB, 4022635AB, 4033938AB, 4033939AB, 4025281AB, 4033937AB, 4025278AB, 4025279AB, 4025280AB, 4033943AB, 4025288AB, 4025282AB, 4025289AB, 4025285AB, 4025286AB, 4025290AB, 4025287AB, 4033934AB, 4033928AB, 4030519AB, 4025291AB, 4025292AB, 4025293AB, 4039970AB, 4039972AB, 4030518AB, 4025295AB, 4039971AB, 4033942AB, 4033927AB, 4033940AB, 4033931AB, 4033930AB, 4033932AB, 4010548AB, 4010551AB, 4033933AB, 4033935AB, 4033936AB, 4039983AB, 4033941AB, 4039973AB, 4039969AB, 4039974AB, 4039987AB, 4039978AB, 4039981AB, 4039975AB, 4039976AB, 4039977AB, 4039979AB, 4039985AB, 4039992AB, 4039988AB, 4039980AB, 4039984AB, 4046424AB, 4039982AB, 4039991AB, 4046419AB, 4039986AB, 4039990AB, 4046422AB, 4039989AB, 4046421AB, 4046423AB, 4046420AB, 4046425AB, 4046430AB, 4046427AB, 4046428AB, 4046426AB, 4046429AB, 4046436AB, 4046431AB, 4058051AB, 4046432AB, 4046437AB, 4046435AB, 4046434AB, 4046433AB, 4046438AB, 4068090, 4071901AB, 4068091, 4068095, 4058044AB, 4058046AB, 4058045AB, 4058047AB, 4058048AB, 4058049AB, 4058050AB, 4058054AB, 4058057AB, 4058062AB, 4058052AB, 4058056AB, 4058063AB, 4058068AB, 4058064AB, 4071892AB, 4071893AB, 4069071AB, 4058066AB, 4071891AB, 4174007AB, 4124420AB, 4146001AB, 4124419AB, 4146000AB, 4147144, 4084056, 4058069AB, 4080944AB, 4058072AB, 4084055, 4058070AB, 4080951AB, 4067648-ENG, 4124438AB, 4124432AB, 4124437AB, 4124439AB, 4146564, 4147141AB, 4174026AB, 4145999AB, 4146002AB, 4147145, 4147143, 4146566, 4146565, 4146567, 4157653AB, 4157654AB, 4158821AB, 4172034, 4163678AB, 4163679AB, 4158820AB, 4163675AB, 4172026AB, 4174012AB, 4174011AB, 4163680AB, 4174016AB, 4174014AB, 4174013AB, 4174643AB, 4174642AB, 4174644AB, 4174641AB, 4174645AB, 4183673AB, 4174646AB, 4174647AB, 4183669AB, 4183007, 4183010, 4183670AB, 4183671AB, 4183672AB, 4183674AB