Biomedix SELEC-3 I.V. Administration Set. Individually recall
Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per…
Why was Biomedix SELEC-3 I.V. Administration Set. Individually recalled?
Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.
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?
Model/Product Number: B30-102 Lot #416130 Exp. 12/2016
- Product
- Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per…
- Recalling firm
- Biomedix, Inc.
- Quantity
- 2,928
- Distribution
- US Distribution including the states of OH, NC, and TX
- Recall date
- October 15, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)