The Recall Desk
HighFDA (Devices)·Z-3061-2024·Announced 2024-09-18

Medline Burn Packs Recalled Due to Syringe Quality Issues

Medline is recalling burn convenience kits because they contain plastic syringes with leaks or breakage risks identified in an FDA Safety Alert.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text states the defects 'may pose a risk to patient health' without reporting specific injuries or hospitalizations, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling specific Medline Convenience kits, including various Burn Packs and Large Burn Packs. These kits contain plastic syringes that are affected by an FDA Safety Alert issued on March 19, 2024.

The recall is due to identified leaks, breakage, and other quality issues in the syringes, which may pose a risk to patient health. The affected products were distributed worldwide.

Consumers and healthcare facilities should check their inventory for the specific pack numbers and lot numbers listed in the recall notice. If the products are found, they should be removed from use and returned to Medline or the distributor as directed.

The recalled product

Product
Medline Convenience kits, labeled as: aa1) BURN PACK-LF, Pack Number DYNJ0781678S ; 2) BURN PACK , Pack Number DYNJ0976092P ; 3) BURN PACK-LF, Pack Number DYNJ42829B ; 4) BURN PACK , Pack Number DYNJ54386C ; 5) LARGE BURN PACK , Pack Number DYNJ69770; 6) LARGE BURN

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)

  • DYNJ0781678S
  • Lot Number 19LMC634
  • Lot Number 20AMD173
  • Lot Number 20CMC665
  • Lot Number 20EMB965
  • Lot Number 20GMC952
  • Lot Number 20JMD288
  • Lot Number 21CMB052
  • Lot Number 21CME303
  • Lot Number 21GME666
  • Lot Number 21IMD184
  • Lot Number 21KMG512
  • Lot Number 22AMF686
  • Lot Number 22BMA737
  • Lot Number 22DMI132
  • Lot Number 22EMB432
  • Lot Number 22EMI061
  • Lot Number 22GMB212
  • Lot Number 22IMC056
  • Lot Number 22KMB510

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 81 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 81 products in this recall →