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Moderate riskFDA DeviceClass II

Medline catheter kits recalled for possible lubricant contamination

Medline convenience kits that include BD Urinary Catheter Trays contain CliniClean Pericare Wipes that were recalled. The wipes may be contaminated with a lubricant used in manufacturing. Use of affected wipes may cause localized skin irritation, redness, or mild inflammation.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

  1. Set aside affected kits and do not use the CliniClean Pericare Wipes in them.
  2. Check for product code DYNJ912762, UDI-DI 10198459776069, and lot 26FMH555. The notice also lists additional product codes and lots of recalled wipes.
  3. The notice doesn't say how to get a replacement or refund; contact Medline Industries, LP or where you purchased the kits.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes SM-VAT DYNJ912762
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 10 products — see all of them.

Details

Units affected
7,043 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, Northfield, Illinois, United States
Classification
Class II
Recall number
Z-0413-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes SM-VAT DYNJ912762 Convenience kits contain additional product codes and lots of recalled CliniClean Pericare Wipes identified by manufacturer. Wipes may be contaminated with a lubricant used in the manufacturing process. Use of affected wipes may cause localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare may increase the risk of localized infection or catheter-associated urinary tract infection. DYNJ912762 UDI-DI 10198459776069 Lot 26FMH555 Distribution: US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IN, LA, MA, MN, MO, MS, MT, NC, NE, NV, NY, OH, OK, RI, SC, TN, TX, WI. Affected quantity: 7,043 kits
Hazard
Convenience kits contain additional product codes and lots of recalled CliniClean Pericare Wipes identified by manufacturer. Wipes may be contaminated with a lubricant used in the manufacturing process. Use of affected wipes may cause localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare may increase the risk of localized infection or catheter-associated urinary tract infection.

10 products in this recall

Medline kits with CliniClean wipes recalled for possible contamination

Medline is recalling 10 convenience kits that include BD Urinary Catheter Trays with CliniClean Pericare Wipes, which may be contaminated with a lubricant used in manufacturing. Use of affected wipes may cause localized skin irritation, redness or mild inflammation, and skipping pericare may increase the risk of local infection or catheter-associated urinary tract infection. The kits were distributed in 24 states, and the notice reports no injuries.

The agency lists each product separately. Check every one you might have.

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