Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterpr
FDA device recall Z-2328-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- Reason for recall
- Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
- Action taken
- The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MDD
- Quantity affected
- 10 units
- Distribution
- Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
- Date initiated
- 2008-07-02
- Date posted
- 2008-09-20
- Date terminated
- 2008-09-22
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.