Recall Weekly
Moderate riskFDA DeviceClass II

Medline kits with CliniClean wipes recalled for possible contamination

Medline convenience kits that include BD urinary catheter trays also contain recalled CliniClean Pericare Wipes from specific lots. 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 them.
  2. Check each kit's product code and lot against the notice, such as DYNJT8877 with lots 26EBB204 and 26GBP480. The notice lists all affected codes and lots.
  3. The notice doesn't say how to get a replacement or refund. Contact Medline Industries or 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 ABDOMINAL HYSTERECTOMY DYNJT8877 LAPAROSCOPIC HYSTERECTOMY DYNJ900244J LAVH DYNJ903392L PELVIC/LAVH/TUBALIGATION T DYNJ910662B WPH MAJOR VAGINAL PACK DYNJ89783 DAVINCI HYSTERECTOMY CDS CDS985344F GYN ABDOMINAL CDS CDS982654L GYN LAP HYSTERECTOMY CDS CDS982662Q LAVH DYNJ909742B
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-0420-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ABDOMINAL HYSTERECTOMY DYNJT8877 LAPAROSCOPIC HYSTERECTOMY DYNJ900244J LAVH DYNJ903392L PELVIC/LAVH/TUBALIGATION T DYNJ910662B WPH MAJOR VAGINAL PACK DYNJ89783 DAVINCI HYSTERECTOMY CDS CDS985344F GYN ABDOMINAL CDS CDS982654L GYN LAP HYSTERECTOMY CDS CDS982662Q LAVH DYNJ909742B 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. DYNJT8877 UDI-DI 10198459764486 Lots 26EBB204 26GBP480 DYNJ900244J UDI-DI 10198459478727 Lots 26ABB104 26CBN466 DYNJ903392L UDI-DI 10198459522758 Lots 25KBE512 25LBA207 DYNJ910662B UDI-DI 10198459477430 Lot 25LBF442 DYNJ89783 UDI-DI 10198459289323 Lots 25LBB743 26ABN735 CDS985344F UDI-DI 10195327312565 Lots 25LBG617 26ABH355 26ABJ895 CDS982654L UDI-DI 10195327306830 Lot 26EBN087 CDS982662Q UDI-DI 10195327306793 Lots 25LBF560 26ABD832 26ABP323 DYNJ909742B UDI-DI 10198459107221 Lots 25LBD208 26ABO287 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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