Moderate riskFDA DeviceClass II

Medline kits with CliniClean wipes recalled for possible contamination

Medline convenience kits that contain BD urinary catheter trays include certain CliniClean Pericare Wipes that were recalled by their manufacturer. The wipes 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 localized infection or catheter-associated urinary tract infection.

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 the wipes in each kit against lots 25KBL876 and 26ABP500 (UDI-DI 10198459556838).
  3. The notice lists kit DYNJ910195A and says the kits contain additional product codes; check all kit codes.
  4. The notice does not say how to get a replacement or refund; contact Medline Industries.

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 UNIVERSAL GYN DYNJ910195A
Sold in
Nationwide
Made for
All ages (under 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-0421-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes UNIVERSAL GYN DYNJ910195A 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. UDI-DI 10198459556838 Lots 25KBL876 26ABP500 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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