Anspach Effort Recalls Irrigation Clip 30 Due to Incorrect Assembly
The Anspach Effort, Inc. is recalling Irrigation Clip 30 units assembled with incorrect smaller front clips. The affected clips were distributed in Pennsylvania, Minnesota, and Switzerland.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall, and the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Anspach Effort, Inc. is recalling Irrigation Clip 30, a medical device intended to position and hold irrigation tubing during surgical procedures. The recall involves 50 clips from Lot # J023101962 (Model/Catalog IRR-Clip-30) that were assembled with the incorrect, smaller front clips (component 44-0495 instead of 44.0498).
The affected units were distributed in the states of Pennsylvania and Minnesota, as well as in Switzerland. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and distributors should stop using the affected clips and contact The Anspach Effort, Inc. for instructions on return or replacement. Patients who have had surgical procedures using these specific clips should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model/Catalog: IRR-Clip-30 Lot # J023101962
Distribution
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