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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Irrigation Clip 40

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 Class 2 Recall
Anspach Irrigation Clip 40
see related information
Date Posted May 16, 2014
Recall Status1 Open
Recall Number Z-1629-2014
Recall Event ID 68021
Premarket Notification
510(K) Number
K030576 
Product Classification Pump, Infusion - Product Code FRN
Product Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
Code Information Batch G323082757.
Recalling Firm/
Manufacturer
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, Florida 33410-4235
For Additional Information Contact Suzanne Goodman
561-494-3706
Manufacturer Reason
for Recall
The Irrigation Clips were assembled with the incorrect (smaller) clips.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The firm, Anspach, sent an URGENT: Medical Device Removal letter dated December 3, 2013 to its customer. The letter described the product, problem and actions to be taken. Should you have any queries, please do not hesitate to contact Aspach Customer Support at (800) 327-6887.
Quantity in Commerce 150
Distribution US Nationwide Distribution in the state of Mississippi.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = THE ANSPACH EFFORT, INC.
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