Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek and LDPE/PET pouch. Secondary packaging inclu
FDA device recall Z-0023-2015 · posted 2014-10-06 · Terminated
Recall details
- Recalling firm
- Biomedix, Inc.
- Reason for recall
- 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.
- Action taken
- Biomedix sent an PRODUCT RECALL NOTIFICATION letter dated August 14, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please contact us with the quantity remaining in inventory or available to be returned to our facility. All units returned to Biomedix will be replaced with the same SELEC-3 item or a similar design at no charge. Please call (1-800-627-2765 ) for further questions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2,928
- Distribution
- US Distribution including the states of OH, NC, and TX
- Date initiated
- 2014-08-14
- Date posted
- 2014-10-06
- Date terminated
- 2014-11-13
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SELEC-3 I.V.ADMINISTRATION SET (K142097) | Biomedix, Inc. | 2014-08-29 |