FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
- Recall number
- Z-1246-2016
- Recalling firm
- The Anspach Effort, Inc.
- Product
- Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
- Status
- Terminated
- Initiated
- 2015-11-02
- Posted
- not on file
- Terminated
- 2016-05-06
- Reason
- Assembled with the incorrect (smaller) front clips (component 44-0495 instead of 44.0498).
- Root cause
- Nonconforming Material/Component
- Action
- On Nov 2, 2015 Anspach sent a letter to their customers informing them of the recall. Customer Immediate Actions: Please complete the attached reply form confirming your receipt of this letter. Return the completed form by fax to the number or email provided on the form. Returning the form promptly will prevent you from receiving repeat notices. If you distribute any of the products to other services or facilities, please forward this information as appropriate. We understand this product recall removal) may have an impact on your facility. The FDA has recommended that healthcare facilities follow their risk management procedures as it relates to this notification. We apologize for any inconvenience that this Product Removal may create and appreciate your cooperation with our request. If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
- Quantity
- 50 clips
- Distribution
- Distributed in the states of PA and MN, and the country of Switzerland.
- Lot, serial or model codes
- Model/Catalog: IRR-Clip-30 Lot # J023101962
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDO
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28