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U.S. Department of Health and Human Services

Class 2 Device Recall PHS Spinal Tray 24G Gertie Marx

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  Class 2 Device Recall PHS Spinal Tray 24G Gertie Marx see related information
Date Initiated by Firm August 24, 2016
Create Date September 21, 2016
Recall Status1 Terminated 3 on December 19, 2016
Recall Number Z-2868-2016
Recall Event ID 75029
510(K)Number K943319  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379.

Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
Code Information Lot Number affected: W1503532
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 W 2400 S Ste 1050
Salt Lake City UT 84119-1135
For Additional Information Contact Dr. Patricia W. Kihn
717-309-3966
Manufacturer Reason
for Recall		 Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
FDA Determined
Cause 2		 Employee error
Action Consignees notified on 8/24/16 via an Urgent - Field Corrective Action letter e-mail. The letter identified the affected device and the reason for the recall. Customers were asked to review their inventory of the Spinal Tray 24 G Gertie Marx to confirm the quantity received. The attached form should be completed and returned by e-mail or fax as indicated. Once the form is received, Customer Service will place an order for the customer to receive replacement devices. Questions should be directed to Customer Service at 1-800-241-2210.
Quantity in Commerce 320 packages
Distribution Distributed to CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CAZ and Original Applicant = SPINAL SPECIALTIES, INC.
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