—#126801

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K030576
Affected lot / code info: Batch G323082757.

Why it was recalled

The Irrigation Clips were assembled with the incorrect (smaller) clips.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: US Nationwide Distribution in the state of Mississippi.

Timeline

Recall initiated: 2013-12-03
Posted by FDA: 2014-05-16
Terminated: 2016-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126801. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.