Reported Apr 11, 2018 · Terminated
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual…
C.R. Bard, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.R. Bard, Inc. · 8195 Industrial Blvd NE · Covington, GA · 30014-1497
Is this the product you have?
- HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
- Lot codes and dates
Item 50610 Lots #'s: JUBT0404JUBP0700JUBR2498JUBS1289
- Amount recalled
- 44640.0 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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