Recall Weekly
Moderate riskFDA DeviceClass II

Medline convenience kits recalled for possible lubricant contamination

Medline convenience kits that include BD urinary catheter trays with CliniClean Pericare Wipes are being recalled. The wipes may be contaminated with a lubricant used in manufacturing. Use of affected wipes may cause localized skin irritation, and 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 do not use them, checking each product code and lot against the notice's list.
  2. Affected kits include product codes such as DYNJ911424, DYNJ903440D and DYNJ62659F, with UDI-DI codes and lot numbers listed in the notice.
  3. The notice does not specify a remedy; contact Medline Industries for next steps.
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 ROBOTIC COLON DYNJ911424 ROBOTIC LITHOTOMY DYNJ903440D ROBOTIC THORACOSCOPY DYNJ910924A RR-LAP DONOR NEP ACCESSORY DYNJ63395D ABDOHYST LAPAEXPL DYNJ910659A C SECTION PACK DYNJ66873C C-SECTION DYNJ911236 DAVINCI GYN PACK DYNJ69169F GENERAL ROBOTIC PACK DYNJ62659F DYNJ62659G GYN/PROSTATE ROBOTIC PACK DYNJ62594D LAPAROTOMY DYNJ911243 LAVH DYNJ87680A OPEN HEART A&B DYNJ911245 PCNL BTGH DYNJT7376 SHELBY ABDOMINAL-UNIVERSAL PK DYNJ62669D SLUH CRANIOTOMY PACK-LF DYNJ0369348T UCSD ACOUSTIC NEUROMA PACK DYNJ59953L
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-0417-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ROBOTIC COLON DYNJ911424 ROBOTIC LITHOTOMY DYNJ903440D ROBOTIC THORACOSCOPY DYNJ910924A RR-LAP DONOR NEP ACCESSORY DYNJ63395D ABDOHYST LAPAEXPL DYNJ910659A C SECTION PACK DYNJ66873C C-SECTION DYNJ911236 DAVINCI GYN PACK DYNJ69169F GENERAL ROBOTIC PACK DYNJ62659F DYNJ62659G GYN/PROSTATE ROBOTIC PACK DYNJ62594D LAPAROTOMY DYNJ911243 LAVH DYNJ87680A OPEN HEART A&B DYNJ911245 PCNL BTGH DYNJT7376 SHELBY ABDOMINAL-UNIVERSAL PK DYNJ62669D SLUH CRANIOTOMY PACK-LF DYNJ0369348T UCSD ACOUSTIC NEUROMA PACK DYNJ59953L 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. DYNJ911424 UDI-DI 10198459341267 Lot 26FMH166 DYNJ903440D UDI-DI 10195327407681 Lot 26ABH105 DYNJ910924A UDI-DI 10198459529047 Lot 26EBC703 DYNJ63395D UDI-DI 10198459783821 Lot 26ELA432 DYNJ910659A UDI-DI 10198459479625 Lot 26BBQ818 DYNJ66873C UDI-DI 10198459511592 Lot 25LBT825 DYNJ911236 UDI-DI 10198459302299 Lot 26ABN933 DYNJ69169F UDI-DI 10198459268793 Lot 26EMB812 DYNJ62659F UDI-DI 10198459174582 Lot 25LBK659 DYNJ62659G UDI-DI 10198459665257 Lot 26ABR665 DYNJ62594D UDI-DI 10198459049767 Lot 25LBJ493 DYNJ911243 UDI-DI 10198459302329 Lots 25KBE169 25LBC079 DYNJ87680A UDI-DI 10198459511028 Lot 26BMD495 DYNJ911245 UDI-DI 10198459302336 Lots 25KBE458 25KBH205 25LBA067 25LBI505 DYNJT7376 UDI-DI 10198459625541 Lot 26BBL872 DYNJ62669D UDI-DI 10198459744792 Lot 26DBD898 DYNJ0369348T UDI-DI 10198459733826 Lot 26FBM787 DYNJ59953L UDI-DI 10198459695803 Lot 26DLA957 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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