Moderate riskFDA DeviceClass II

Medline convenience kits recalled for possible lubricant contamination

Medline convenience kits that include BD Urinary Catheter Trays and 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, 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. Stop using affected kits and set them aside.
  2. Check kit product codes and lots: DYNJ912347 (ENT-MICRO) lot 26EMA878; DYNJ911420A (Laminectomy) lot 26HMM122; DYNJT6104 (Non MB Major Neuro Cranial Small Pack) lot 26BBE722; DYNJ911856 (Spine) lot 26DMI925.
  3. The notice doesn't say how to get a replacement or refund; contact Medline Industries.

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 ENT-MICRO DYNJ912347 LAMINECTOMY DYNJ911420A NON MB MJR NEURO CRANI SM PK DYNJT6104 SPINE DYNJ911856
Sold in
Nationwide
Made for
All ages

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-0422-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes ENT-MICRO DYNJ912347 LAMINECTOMY DYNJ911420A NON MB MJR NEURO CRANI SM PK DYNJT6104 SPINE DYNJ911856 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. DYNJ912347 UDI-DI 10198459699757 Lot 26EMA878 DYNJ911420A UDI-DI 10198459745416 Lot 26HMM122 DYNJT6104 UDI-DI 10198459539374 Lot 26BBE722 DYNJ911856 UDI-DI 10198459559068 Lot 26DMI925 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.

More from Medline

See all

Related topics