CareFusion Endoscopic Equipment Recalled for Missing Instructions for Use
CareFusion endoscopic equipment packages did not contain required instructions for use. The recall affects 152 units distributed to healthcare facilities in the US and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling defect—missing Instructions for Use on the device package. No illnesses or injuries have been reported. The hazard is documentation-related rather than a product defect or confirmed harm.
Plain-English summary
CareFusion 2200 Inc is recalling four models of Snowden-Pencer endoscopic equipment: the 10 mm endoscope (Catalog #88-5910), 5 mm endoscope (Catalog #88-5920), and two MIS endoplastic fittings (Catalog #88-9808 and #88-9809). A total of 152 units were affected.
The finished device packages did not contain the Instructions for Use (IFU), which are necessary for proper assembly, operation, and safe use of the equipment.
The affected equipment was distributed nationwide in the United States to facilities in Alabama, Arizona, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Montana, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, and Wisconsin. International distribution included Taiwan and Australia.
The recalled product
- Product
- (a) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 10 mm, 30 degrees 7", 17.5 cm, Catalog #88-5910; (b) CareFusion Snowden-Pencer Plastics, Endoplastic Endoscope 5 mm, 30 degrees 7", 17.5 cm, Catalog #88-5920; (c) CareFusion Snowden-Pencer MIS, Endoplastic Fitting, S
- Manufacturer
- Carefusion 2200 Inc
- Hazard
- missing-instructions
- labeling-defect
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 (20)
- (a) Catalog #88-5910 - Lot numbers C17XRD and K17XRD
- UDI 10885403153341
- (b) Catalog #88-5920 - Lot numbers XRDX02
- XRDZ07
- K17XRD
- C18XRD
- G18XRD
- C19XRD
- D20XRD
- G20XRD
- J19XRD
- K19XRD
- UDI 10885403153358
- (c) Catalog #88-9808 - Lot numbers XRDV09
- 864909
- UDI 10885403155314
- and (d) Catalog #88-9809 - Lot numbers XRDV09
- XRDV10
- XRDX06
- B18XRD
Distribution
Distributed nationwide across the United States.
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