The Recall Desk
HighFDA (Devices)·Z-0157-2025·Announced 2024-10-30

Medline medical procedure kits recalled due to potential non-sterile packaging defect

Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.

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 medical procedure kits where the packaging defect could result in non-sterile product being used during invasive procedures. While the hazard is theoretical with no reported illnesses or injuries, this meets the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling certain medical procedure convenience kits that were packaged in breather pouch lot 323080002. The affected products include line insertion trays, PICC packs, central line packs, and related procedural convenience kits.

The breather pouches in lot 323080002 may fail to maintain product sterility if the vendor seal is opened or unsealed. This could result in non-sterile supplies being used during medical procedures, creating a risk of infection or complications.

These kits have been distributed in the United States, Canada, and Panama to healthcare facilities and medical suppliers.

Healthcare facilities should verify they do not have affected kits from this lot number and contact Medline Industries for further instructions or product replacement. Affected kits should not be used.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Sterile Procedure Kits
Hazard
  • non-sterile
  • packaging-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 (20)

  • a) REF CVI4730A
  • UDI/DI 40195327562039 (each)
  • 10195327562038 (case)
  • Lot Numbers: 24ABK903
  • b) REF CVI4730A
  • Lot Numbers: 23LBN351
  • c) REF DYNJ20803D
  • UDI/DI 40889942553885 (each)
  • 10889942553884 (case)
  • Lot Numbers: 24ABE939
  • d) REF DYNJ28368
  • UDI/DI 40080196200161 (each)
  • 10080196200160 (case)
  • Lot Numbers: 24ABD995
  • e) REF DYNJ28368
  • UDI/DI UDI/DI 40080196200161 (each)
  • Lot Numbers: 23KBE939
  • f) REF DYNJ28487
  • UDI/DI 40080196227021 (each)
  • 10080196227020 (case)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category