Medline sterile convenience kits recalled for weak breather pouch seals
Medline is recalling sterile convenience kits due to weak or open seals on breather pouches used for packaging. Compromised seals could allow contamination of sterile medical devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This Class II FDA recall involves a packaging defect on sterile medical devices. No illnesses or injuries have been reported. The recall is precautionary, addressing weak seals that could theoretically allow contamination of otherwise sterile products.
Plain-English summary
Medline Industries is recalling five models of sterile convenience kits used in various medical procedures. The affected kits are: NEURO PACK WRO-LF (Model DYNJ41856C), STIM IMPLANT PACK (Model DYNJ53032C), WMC VP SHUNT PACK-LF (Model DYNJ50629M), SHUNT PACK (Model DYNJ40040C), and STIM IMPLANT PACK (Model DYNJ53032C). A total of 354 units were distributed.
The recall addresses a potential for weak or open seals on breather pouches used to package these sterile kits. Breather pouches are designed to maintain sterility of medical devices during storage and distribution. If seals are compromised, bacteria or other contaminants could potentially reach the otherwise sterile products.
The affected products were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. Specific lot numbers have been identified for each model: Lot 24JBM711 (DYNJ41856C), Lot 24JBN788 (DYNJ53032C), Lot 24JBW674 (DYNJ50629M), Lot 24KBC507 (DYNJ40040C), and Lot 24KBC655 (DYNJ53032C). Healthcare providers and facilities should verify receipt of these lot numbers and contact Medline for guidance.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model N
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterile-package-compromise
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 (18)
- 1) DYNJ41856C
- UDI-DI: 10195327429010(each)
- 40195327429011(case)
- Lot Number: 24JBM711
- 2) DYNJ53032C
- UDI-DI: 10195327494094(each)
- 40195327494095(case)
- Lot Number: 24JBN788
- 3) DYNJ50629M
- UDI-DI: 10198459146985(each)
- 40198459146986(case)
- Lot Number: 24JBW674
- 4) DYNJ40040C
- UDI-DI: 10889942683970(each)
- 40889942683971(case)
- Lot Number: 24KBC507
- 5) DYNJ53032C
- Lot Number: 24KBC655
Distribution
Distributed nationwide across the United States.
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