Recall Weekly
Moderate riskFDA DeviceClass II

Medline C-section kits recalled for possible wipe contamination

Medline convenience kits that include BD Urinary Catheter Trays and CliniClean Pericare Wipes are being recalled. The wipes in these kits may be contaminated with a lubricant used in manufacturing, which may cause localized skin irritation, redness, or mild inflammation. Failure to perform pericare may increase the risk of localized infection or catheter-associated urinary tract infection. About 7,043 kits were distributed nationwide in 24 states.

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

What to do

  1. Set aside kits with the product codes listed in the notice (DYNJ911835B, DYNJ906557D, DYNJ911835, DYNJ905096F, DYNJ903456C) and do not use them.
  2. Check each kit's product code and lot number against the lists in the notice to confirm whether it is affected.
  3. The notice does not specify a remedy; contact Medline Industries, LP for instructions on return or replacement.
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 C-SECTION DYNJ911835B C-SECTION PACK DYNJ906557D C-SECTION-LF DYNJ911835 C SECTION DYNJ905096F C-SECTION DYNJ903456C
Sold in
Nationwide
Made for
Adults (0 months and older)

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-0419-2027

In the FDA's words

Description
Medline convenience kits containing BD Urinary Catheter Trays that include CliniClean Pericare Wipes C-SECTION DYNJ911835B C-SECTION PACK DYNJ906557D C-SECTION-LF DYNJ911835 C SECTION DYNJ905096F C-SECTION DYNJ903456C 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. DYNJ911835B UDI-DI 10198459686047 Lots 26EBN595 26FBG291 DYNJ906557D UDI-DI 10198459476303 Lots 25LBT491 26ABM644 26CBU464 26DBD089 DYNJ911835 UDI-DI 10198459551956 Lots 25LBC062 25LBC230 25LBR990 26ABI623 DYNJ905096F UDI-DI 10198459071027 Lot 26HMM443 DYNJ903456C UDI-DI 10193489668087 Lots 26ABJ223 26DBA167 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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