Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. A k
FDA device recall Z-2194-2011 · posted 2011-05-13 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Outer packaging of Combo Kit was mislabeled with an incorrect lot number.
- Action taken
- Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HBG
- Quantity affected
- 7 Kits
- Distribution
- Nationwide Distribution -- including the state of New York.
- Date initiated
- 2011-02-22
- Date posted
- 2011-05-13
- Date terminated
- 2011-05-13
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CNS INTERCHANGEABLE BIT CRANIAL DRILL (K961113) | Clinical Neuro Systems, LLC | 1996-06-05 |