Recall Weekly
Moderate riskFDA DeviceClass II

Medline convenience kits recalled for possible wipe contamination

Medline convenience kits containing BD Urinary Catheter Trays include CliniClean Pericare Wipes that may be contaminated with a lubricant used in manufacturing. Use of affected wipes may cause localized skin irritation, redness or mild inflammation. Not performing 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 and stop using the affected kits.
  2. Match each kit's product code and lot number to the notice. Affected codes include DYKS1120G, CDS983346K, DYNJT5258A, DYNJ912460, CDS982028W, CDS980895X, DYNJ911429 and DYNJ908362F.
  3. Check the full product list in the notice, since the kits contain additional product codes and lots of recalled wipes.
  4. The notice doesn't say how to get a replacement or refund; contact Medline Industries, LP.
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 ADULT HEART CIRCULATOR KIT DYKS1120G AHT CVOR CABG CDS983346K CARDIOPULMONARY MPH DYNJT5258A CV HEART GOWN & DRAPE PACK A DYNJ912460 FEM POP CDS982028W OPEN HEART PROCEDURE CDS980895X VASCULAR DYNJ911429 ENDOSCOPIC SKULL BASE DYNJ908362F
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-0414-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ADULT HEART CIRCULATOR KIT DYKS1120G AHT CVOR CABG CDS983346K CARDIOPULMONARY MPH DYNJT5258A CV HEART GOWN & DRAPE PACK A DYNJ912460 FEM POP CDS982028W OPEN HEART PROCEDURE CDS980895X VASCULAR DYNJ911429 ENDOSCOPIC SKULL BASE DYNJ908362F 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. DYKS1120G UDI-DI 10198459335808 Kit lots 26DMI051 26EMJ713 CDS983346K UDI-DI 10198459701993 Kit lot 26DBH084 DYNJT5258A UDI-DI 10198459661495 Kit lot 26DBB503 DYNJ912460 UDI-DI 10198459726880 Kit lot 26DLA824 CDS982028W UDI-DI 10198459385605 Kit lot 25LMH727 CDS980895X UDI-DI 10198459662904 Kit lot 26EMA865 DYNJ911429 UDI-DI 10198459341014 Kit lots 26AMJ586 26CMF189 26FME829 26FMG294 DYNJ908362F UDI-DI 10198459308581 Kit lot 25LLA930 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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