The Recall Desk
HighFDA (Devices)·Z-2630-2024·Announced 2024-09-04

Medline dialysis procedure packs recalled for syringe leaks and breakage

Medline procedure packs containing Shenli syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall involves 1,679,067 units distributed worldwide.

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: This is an FDA Class II recall of syringes in medical procedure packs. No illnesses or injuries have been reported; the hazard is potential risk from leaks, breakage, and quality issues. Per the severity rubric, this qualifies as High (score 3): a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling medical procedure packs used in dialysis care procedures. The packs contain Shenli syringes that are affected by an FDA Safety Alert issued on March 19, 2024. The syringes have been found to have leaks, breakage, and other quality issues that may pose a risk to patient health. A total of 1,679,067 units are involved in this recall.

The affected packs have been distributed worldwide. There are five different types of packs being recalled, with specific lot numbers identified for each type. Affected lot numbers include: 23IBE112, 23JBH284, 23KBE900, 23LBO850 (for Dialysis Cath Access Kit); 23FBK320, 23GBU834, 23HBG572, 23LBL499 (for Dialysis Pack); 21IMD970, 21KMA999 (for Dialysis AV Shunt); 24CDB254 (for Dialysis Access Pack); and 23KBL354 (for No Cath Dialysis Insertion Tray).

Healthcare providers and patients who have these products should check their pack numbers and lot numbers against the recall information. Do not use any affected packs. Contact Medline Industries for instructions on replacement or proper disposal of recalled products.

The recalled product

Product
Medline procedure packs containing Shenli syringes, labeled as follows: 1) DIALYSIS CATH ACCESS KIT, Pack Number DYNDA2516B ; 2) DIALYSIS PACK , Pack Number DYNJ36932A ; 3) DIALYSIS AV SHUNT #668229-V-LF, Pack Number DYNJ58502C ; 4) DIALYSIS ACCESS PACK, Pack Number DYNJ91
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Dialysis / Medical Syringes
Hazard
  • leak
  • breakage
  • quality-defect

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 (17)

  • DYNDA2516B
  • Lot Number 23IBE112
  • Lot Number 23JBH284
  • Lot Number 23KBE900
  • Lot Number 23LBO850
  • DYNJ36932A
  • Lot Number 23FBK320
  • Lot Number 23GBU834
  • Lot Number 23HBG572
  • Lot Number 23LBL499
  • DYNJ58502C
  • Lot Number 21IMD970
  • Lot Number 21KMA999
  • DYNJ910121
  • Lot Number 24CDB254
  • PICCNC0028
  • Lot Number 23KBL354

Distribution

Distribution scope not specified by the agency.

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