Medline spinal injection kits recalled for quality and efficacy concerns
Medline Industries recalls 30,120 spinal injection kits containing Huons Bupivacaine due to quality control failures and reported efficacy complaints. The FDA Class I recall affects kits distributed in the US and selected territories.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity rating of 4. The recall involves critical quality control failures in microbiology testing data integrity and reported efficacy complaints for spinal anesthetic injections, which are relied upon for safe surgical procedures.
Plain-English summary
Medline Industries is recalling 30,120 spinal injection kits that contain Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. The affected kits include eight different Medline models identified by their respective SKUs and lot numbers, distributed throughout the United States, Virgin Islands, Bahamas, Panama, and Barbados.
The recall was initiated due to quality issues related to the Huons-supplied Bupivacaine component. Specifically, there are concerns regarding microbiology testing data integrity and reported efficacy complaints. These issues raise questions about the reliability of quality testing and the medication's ability to function as intended in spinal anesthesia procedures.
Patients or healthcare providers who have administered or received these spinal injection kits should contact Medline Industries or their healthcare provider for guidance. The manufacturer can verify affected lot numbers and provide instructions for product disposition or replacement.
The recalled product
- Product
- Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA1097; 2) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1154; 3) SPINAL TRAY, Medline Kit SKU DYNJRA1192A; 4) BLOCK TRAY, Medline
- Manufacturer
- Medline Industries, LP
- Hazard
- data-integrity
- efficacy-failure
- quality-control
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline Kit SKU DYNJRA1097: UDI/DI 10889942879236 each
- 40889942879237 case
- Lot Number 26BBJ392
- Lot Number 26ABS354
- Lot Number 25LBC413
- Lot Number 25IBK142
- Lot Number 25FBD584
- Lot Number 25BBK828
- Lot Number 24FBT398
- Lot Number 24BBR608
- Lot Number 23JBB581
- Lot Number 23IBQ010
- Lot Number 23HBM569
- Medline Kit SKU DYNJRA1154: UDI/DI 10889942935864 each
- 40889942935865 case
- Lot Number 26AMK346
- Lot Number 25KMG102
- Lot Number 25JMA641
- Lot Number 25GMC349
- Lot Number 25DMG474
Distribution
Distributed nationwide across the United States.
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