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Serious riskFDA DeviceClass I

Medline convenience kits recalled for bupivacaine quality issues

Medline Industries is recalling specific surgical convenience kits used in joint replacement procedures because they contain a pain-reliever medication (Bupivacaine Hydrochloride in Dextrose) with quality problems. The medication was manufactured by Huons Co, Ltd. and distributed through B. Braun Medical. The quality issues were identified by the supplier and no injuries have been reported.

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

What to do

  1. Check if your facility received any of the affected kits by matching the SKU numbers and lot numbers listed in the recall notice
  2. Do not use affected kits for surgical procedures
  3. Contact Medline Industries or your supplier immediately if you have affected kits
  4. Follow your facility's procedures for handling recalled medical devices
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J; 6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K; 7) TOTAL HIP, Medline Kit SKU DYNJ906665G; 8) TOTAL KNEE, Medline Kit SKU DYNJ906666J; 9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A; 10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A; 11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B; 12) TOTAL JOINT, Medline Kit SKU DYNJ909069B; 13) TOTAL KNEE, Medline Kit SKU DYNJ909070C; 14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B; 15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C; 16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534; 17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A; 18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B; 19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F; 20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D; 21) TOTAL KNEE, Medline Kit SKU DYNJ909643D; 22) TOTAL KNEE, Medline Kit SKU DYNJ909643F; 23) TOTAL JOINT, Medline Kit SKU DYNJ910002A; 24) TOTAL KNEE, Medline Kit SKU DYNJ910354A; 25) TOTAL HIP, Medline Kit SKU DYNJ910813; 26) ANTERIOR HIP, Medline Kit SKU DYNJ911083.
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 3 products — see all of them.

Details

Units affected
2301 kits
Illnesses reported
None reported
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Classification
Class I
Recall number
Z-2749-2026

In the FDA's words

Description
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J; 3) TOTAL HIP, Medline Kit SKU DYNJ903492K; 4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I; 5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J; 6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K; 7) TOTAL HIP, Medline Kit SKU DYNJ906665G; 8) TOTAL KNEE, Medline Kit SKU DYNJ906666J; 9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A; 10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A; 11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B; 12) TOTAL JOINT, Medline Kit SKU DYNJ909069B; 13) TOTAL KNEE, Medline Kit SKU DYNJ909070C; 14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B; 15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C; 16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534; 17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A; 18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B; 19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F; 20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D; 21) TOTAL KNEE, Medline Kit SKU DYNJ909643D; 22) TOTAL KNEE, Medline Kit SKU DYNJ909643F; 23) TOTAL JOINT, Medline Kit SKU DYNJ910002A; 24) TOTAL KNEE, Medline Kit SKU DYNJ910354A; 25) TOTAL HIP, Medline Kit SKU DYNJ910813; 26) ANTERIOR HIP, Medline Kit SKU DYNJ911083. 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. Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25ELB079; Medline Kit SKU DYKS1574A, UDI/DI 10198459147449 (each) 40198459147440 (case), Kit Lot Number 25DLA930; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25IBN992; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25HBS205; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25DBH984; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25CBB436; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 25ABR220; Medline Kit SKU DYNJ902378J, UDI/DI 10198459128813 (each) 40198459128814 (case), Kit Lot Number 24LBI991; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBR847; Medline Kit SKU DYNJ903492K, UDI/DI 10198459255199 (each) 40198459255190 (case), Kit Lot Number 25CBE741; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 25ADA380; Medline Kit SKU DYNJ903493I, UDI/DI 10195327565510 (each) 40195327565511 (case), Kit Lot Number 24KDA993; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA748; Medline Kit SKU DYNJ903493J, UDI/DI 10198459255052 (each) 40198459255053 (case), Kit Lot Number 25CDA157; Medline Kit SKU DYNJ903493K, UDI/DI 10198459293122 (each) 40198459293123 (case), Kit Lot Number 25DDA444; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25GDA109; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25FDB471; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25EDB817; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 25BDA465; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDB209; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24LDA032; Medline Kit SKU DYNJ906665G, UDI/DI 10195327092481 (each) 40195327092482 (case), Kit Lot Number 24KDB063; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 25ABU735; Medline Kit SKU DYNJ906666J, UDI/DI 10195327129590 (each) 40195327129591 (case), Kit Lot Number 24LBU076; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25EBN666; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25DBF470; Medline Kit SKU DYNJ909000A, UDI/DI 10195327428327 (each) 40195327428328 (case), Kit Lot Number 25CBA048; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25FBH718; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25EBF688; Medline Kit SKU DYNJ909002A, UDI/DI 10195327428334 (each) 40195327428335 (case), Kit Lot Number 25DBO19
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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