BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for use as an adjunct to sta
FDA device recall Z-1674-2014 · posted 2014-05-30 · Terminated
Recall details
- Recalling firm
- CryoLife, Inc.
- Reason for recall
- Serum albumin component monomer failed to meet internally established end of shelf-life specification.
- Action taken
- All consignees were notified of the voluntary actions by issuance of Field Correction/Removal Notice on April 24, 2014. This notices states which lot numbers are to be returned, and which lot numbers can be relabeled with a corrected expiration date.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MUQ
- Quantity affected
- 6190 units
- Distribution
- Distributed Nationwide including Puerto Rico and the states of AL, AK,AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM , NY, NC, ND, OH, OK, O
- Date initiated
- 2014-04-25
- Date posted
- 2014-05-30
- Date terminated
- 2014-11-10
- Location
- Kennesaw, GA
Monitor recalls programmatically
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