Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole acce

FDA device recall Z-0551-2014 · posted 2013-12-20 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Reason for recall

Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.

Action taken

Integra sent an Urgent Voluntary Medical Device Recall letter dated November 26, 2013, to all affected consignees. The letter identified the product, the problem, the action to be taken by the consignee and included a Recall Acknowledgement and Return form. Consignees were instructed to review their inventory and determine if they have any affected product, stop using the affected product immediately and remove from service. Consignees were instructed to complete the attached form even if they do not have the affected product in their inventory and return by email or fax as indicated on the form. When the form is received Customer Service will send an RMA number and directions to return the product. Customers with questions were instructed to contact Customer Service at 1-855-532-1723 or their Integra sales representative at 909-201-4099. For questions regarding this recall call 609-936-6822.

Root cause

Labeling mix-ups

Status

Terminated

Product code

JXG

Quantity affected

731

Distribution

Nationwide Distribution

Date initiated

2013-11-26

Date posted

2013-12-20

Date terminated

2014-04-09

Location

Salt Lake City, UT

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