Recall Weekly
Moderate riskFDA DeviceClass II

Medline convenience kits recalled for possible wipe contamination

Medline convenience kits contain BD Urinary Catheter Trays with CliniClean Pericare Wipes that were recalled by the wipe manufacturer. 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 raise the risk of local infection or catheter-associated urinary tract infection.

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

What to do

  1. Set aside the affected kits and do not use them until you have contacted Medline.
  2. Check the product code and lot number on each kit against the full list in the notice, which includes 10 kit codes with UDI-DI numbers and specific lots.
  3. The notice does not say how to get a replacement or refund; contact Medline or the supplier where the kits were purchased.
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 CHEST/BREAST DYNJ908433F COLON DYNJ904031C DIAGNOSTIC LAP DYNJ900573I EAST MAJOR DYNJ900958C GENERAL LAPAROTOMY PACK- ESCO PHS825461003F GENERAL LAPAROTOMY POWAY DYNJT3500A GYN LAPAROSCOPY CDS CDS985204B LAP COLON DYNJ901360G MAJOR PROCEDURE CDS982040U OPERATIVE LAP P&S SURGICAL DYNJ89608
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-0415-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes CHEST/BREAST DYNJ908433F COLON DYNJ904031C DIAGNOSTIC LAP DYNJ900573I EAST MAJOR DYNJ900958C GENERAL LAPAROTOMY PACK- ESCO PHS825461003F GENERAL LAPAROTOMY POWAY DYNJT3500A GYN LAPAROSCOPY CDS CDS985204B LAP COLON DYNJ901360G MAJOR PROCEDURE CDS982040U OPERATIVE LAP P&S SURGICAL DYNJ89608 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. DYNJ908433F UDI-DI 10198459544293 Lots 26AMF626 26AMG869 26DMD786 DYNJ904031C UDI-DI 10198459223518 Lot 26CBN236 DYNJ900573I UDI-DI 10198459551840 Lot 26CBR773 DYNJ900958C UDI-DI 10195327599454 Lots 25LBR186 26CBR774 PHS825461003F UDI-DI 10198459381249 Lots 26DMH776 26FME340 DYNJT3500A UDI-DI 10198459380907 Lot 26CMJ848 CDS985204B UDI-DI 10889942942039 Lot 25LBE036 DYNJ901360G UDI-DI 10198459224836 Lot 26CBM726 CDS982040U UDI-DI 10198459385421 Lot 25LMH746 DYNJ89608 UDI-DI 10198459279324 Lots 25KBG342 25KBO745 25LBP821 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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