[Recalled] REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, — There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needl… | FDA 2022-04-22

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Bard Peripheral Vascular Inc

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• BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone. — Class II
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• GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310 — Class II
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.