Recall Weekly
Moderate riskFDA DeviceClass II

Medline kits with CliniClean wipes recalled for possible contamination

Medline is recalling convenience kits that contain BD urinary catheter trays and CliniClean Pericare Wipes from specific manufacturer lots. The wipes may be contaminated with a lubricant used in manufacturing, which 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 affected kits and CliniClean Pericare Wipes from the lots listed in the notice, and do not use them.
  2. Check each kit's product code and each wipe lot number against the lists in the notice to identify affected items.
  3. The notice does not specify a remedy, so contact Medline Industries for instructions on returning or disposing of affected 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 DAVINCI DYNJ906763C GYN ABDOMINAL ONCOLOGY DYNJ911414A GYN LAPAROSCOPIC PACK DYNJ909394B GYN LAPAROSCOPY DYNJ903449D DYNJ904701J GYN ROBOTIC CDS984076J DYNJ910181A DYNJ910181C GYN ROBOTIC ADD ON PACK DYNJ43837D OH GYN/LAP ROBOT PACK DYNJ89759 ROBOT ME RF DYNJ900203N ROBOTIC DYNJ903485K ROBOTIC COLON CDS CDS984953J ROBOTIC GU/GYN CDS983393L CDS983393M ROBOTIC GYN DYNJ905230K SOLK GYN-LAP ROBOT PACK DYNJT10414 W&I ROBOT DYNJ910664A WPH GYN LAPAROSCOPY PACK DYNJ89781 DYNJ89781A
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-0418-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes DAVINCI DYNJ906763C GYN ABDOMINAL ONCOLOGY DYNJ911414A GYN LAPAROSCOPIC PACK DYNJ909394B GYN LAPAROSCOPY DYNJ903449D DYNJ904701J GYN ROBOTIC CDS984076J DYNJ910181A DYNJ910181C GYN ROBOTIC ADD ON PACK DYNJ43837D OH GYN/LAP ROBOT PACK DYNJ89759 ROBOT ME RF DYNJ900203N ROBOTIC DYNJ903485K ROBOTIC COLON CDS CDS984953J ROBOTIC GU/GYN CDS983393L CDS983393M ROBOTIC GYN DYNJ905230K SOLK GYN-LAP ROBOT PACK DYNJT10414 W&I ROBOT DYNJ910664A WPH GYN LAPAROSCOPY PACK DYNJ89781 DYNJ89781A 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. DYNJ906763C UDI-DI 10198459551833 Lots 25LBR121 26CBS290 DYNJ911414A UDI-DI 10198459670428 Lot 26FMI519 DYNJ909394B UDI-DI 10198459556579 Lots 25KBE469 26ABO368 DYNJ903449D UDI-DI 10195327407520 Lot 26CBN427 DYNJ904701J UDI-DI 10198459373060 Lot 26BDA186 CDS984076J UDI-DI 10198459283147 Lots 26CBD748 26DBA124 26DBC215 DYNJ910181A UDI-DI 10198459556586 Lots 25KLA664 26ALA732 26ALA897 DYNJ910181C UDI-DI 10198459780950 Lot 26ELA453 DYNJ43837D UDI-DI 10195327657222 Lot 26EMJ002 DYNJ89759 UDI-DI 10198459289286 Lots 25KBK074 25KBQ997 26ABN671 DYNJ900203N UDI-DI 10198459510144 Lots 26ABX032 26BBC420 26CBS914 DYNJ903485K UDI-DI 10198459255083 Lot 26BDA988 CDS984953J UDI-DI 10198459641367 Lots 26ABP040 26DBB664 CDS983393L UDI-DI 10198459224614 Lots 25LBC619 25LBH230 26ABI772 CDS983393M UDI-DI 10198459641350 Lot 26DBA175 DYNJ905230K UDI-DI 10198459520532 Lots 26CBF509 26CBQ707 DYNJT10414 UDI-DI 10198459792441 Lot 26FBE035 DYNJ910664A UDI-DI 10198459178672 Lot 26ABB917 DYNJ89781 UDI-DI 10198459289521 Lots 25LBR578 26CBK466 DYNJ89781A UDI-DI 10198459794933 Lot 26FBL798 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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