Presource Kits containing the Teleflex Pilling Wecksorb Neurosponge — nose/nasal packs (catalogue SEN30NASHA, lots 66924, 888632, 763221, 979790, 73211, 113957, 903987, 137444, 13011), FESS packs (SEN30FESHA, lots 953591, 969830, 912421), craniotomy packs (SNE30PCJHG, lots 890614, 345748, 392056, 78310, 815979) and basic ENT packs (SEN30ENEUA, lots 282990, 334775, 369405) are affected. They were recalled because of out-of-specification or potential out-of-specification levels of endotoxin; contact the manufacturer for additional information.
What's being recalled
Companies: Cardinal Health 200, Llc Also Trading As Cardinal Health, 3651 Birchwood Drive, Waukegan, Illinois, United States, 60085.
How to identify it
Affected products: Nose/Nasal Packs; Lot or serial number: 66924; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 888632; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 763221; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 979790; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 73211; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 113957; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 903987; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 137444; Model or catalogue number: SEN30NASHA
Affected products: Nose/Nasal Packs; Lot or serial number: 13011; Model or catalogue number: SEN30NASHA
Affected products: Functional Endoscopic Sinus Surgery (Fess) Packs; Lot or serial number: 953591; Model or catalogue number: SEN30FESHA
Affected products: Functional Endoscopic Sinus Surgery (Fess) Packs; Lot or serial number: 969830; Model or catalogue number: SEN30FESHA
Affected products: Functional Endoscopic Sinus Surgery (Fess) Packs; Lot or serial number: 912421; Model or catalogue number: SEN30FESHA
Affected products: Craniotomy Packs; Lot or serial number: 890614; Model or catalogue number: SNE30PCJHG
Affected products: Craniotomy Packs; Lot or serial number: 345748; Model or catalogue number: SNE30PCJHG
Affected products: Craniotomy Packs; Lot or serial number: 392056; Model or catalogue number: SNE30PCJHG
Affected products: Craniotomy Packs; Lot or serial number: 78310; Model or catalogue number: SNE30PCJHG
Affected products: Craniotomy Packs; Lot or serial number: 815979; Model or catalogue number: SNE30PCJHG
Affected products: Basic Ear/Nose/Throat (Ent) Packs; Lot or serial number: 282990; Model or catalogue number: SEN30ENEUA
Affected products: Basic Ear/Nose/Throat (Ent) Packs; Lot or serial number: 334775; Model or catalogue number: SEN30ENEUA
Affected products: Basic Ear/Nose/Throat (Ent) Packs; Lot or serial number: 369405; Model or catalogue number: SEN30ENEUA
The hazard
Cardinal Health was recently informed of a medical device recall from Teleflex concerning the Pilling® Wecksorb Neurosponge referenced. The recall is being issued due to out-of-specification, or potential out-of-specification levels of endotoxin.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)