Infusion Set recall
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort…
Why was Infusion Set recalled?
Tubing detachment
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
5021247, 5021251, 5021253, 5029813, 5031819, 5031820, 5031821, 5031822, 5031823, 5032577, 5032578, 5033752, 5033753, 5033754, 5033755, 5034062, 5034063, 5034064, 5034199, 5034200, 5035085, 5035086, 5035098, 5035099, 5035100, 5037024, 5037025, 5038106, 5038107, 5038108, 5038109, 5038110, 5040382, 5040939, 5040940, 5040941, 5040942, 5040943, 5040944, 5040945, 5040946, 5041053, 5041054, 5041055, 5041056, 5041057, 5043820, 5044874, 5044875, 5044876, 5044877, 5044878, 5044879, 5044880, 5044881, 5044882, 5047110, 5047111, 5047112, 5047113, 5047115, 5047116, 5047117, 5047118, 5047119, 5047121, 5051915, 5053663, 5053664, 5053665, 5053666, 5053667, 5053668, 5053669, 5053670, 5054453, 5054455, 5054456, 5054457, 5054458, 5054459, 5054460, 5054467, 5056817, 5056855, 5056856, 5056857, 5058622, 5058632, 5058636, 5058638, 5058639, 5058640, 5058641, 5058642, 5058735, 5060034, 5060036, 5060037, 5060038, 5060042, 5062768, 5062779, 5062781, 5062782, 5062783, 5062796, 5062814, 5062815, 5065701, 5066393, 5066981, 5066984, 5066992, 5067121, 5067122, 5067123, 5067124, 5067126, 5067127, 5067128, 5067129, 5067130, 5067131, 5067132, 5067133, 5067134, 5067137, 5070832, 5071891, 5071892, 5075507, 5075508, 5075510, 5075533, 5076039, 5077501, 5035530, 5035531, 5035532, 5054472, 5054473, 5054474, 5054479, 5054480, 5063759, 5063760, 5063761
- Product
- Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort…
- Recalling firm
- Unomedical As
- Quantity
- 1,295,515 units
- Distribution
- Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.
- Recall date
- November 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)