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Serious riskFDA DeviceClass I

Medline C-section kits recalled for bupivacaine quality issues

Medline Industries is recalling specific C-section convenience kits (SKU DYNJ910835 and DYNJ910835A) that contain an anesthetic medication with quality problems. The anesthetic, Bupivacaine Hydrochloride in Dextrose Injection, was recalled by its manufacturer due to quality issues.

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

What to do

  1. Check if you have Medline C-section kits with SKU DYNJ910835 or DYNJ910835A and lot numbers 25BBC541 or 25DBP805.
  2. Do not use the kits if you have them.
  3. Contact Medline Industries or your healthcare facility for instructions on safe disposal and replacement.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Sold in
US: OH, CA, IL, IN, FL, SC, AZ, NJ.
Made for
Adults (15 years to 50 years)

This recall covers 3 products — see all of them.

Details

Units affected
56 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-2748-2026

In the FDA's words

Description
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues. 1) Medline SKU DYNJ910835: 10198459152849 (each) 40198459152840 (case) Kit Lot Number 25BBC541; 2) Medline SKU DYNJ910835A: 10198459252570 (each) 40198459252571 (case), Kit Lot Number 25DBP805. Distribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ. Affected quantity: 56 kits
Hazard
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.

3 products in this recall

Medline convenience kits recalled for bupivacaine quality issues

Medline is recalling three kit products that contain a bupivacaine hydrochloride injection, a numbing medication used in surgery. The bupivacaine maker issued a voluntary recall over quality issues, so Medline is recalling the kits that include it. About 2,417 kits are affected, distributed in OH, CA, IL, IN, FL, SC, AZ, and NJ.

The agency lists each product separately. Check every one you might have.

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