Medline Irrigation Kits and Packs Recalled for Sterility Defect
Medline Industries recalls 279 irrigation and saline kits, trays, and packs due to potential lack of sterility in components used to manufacture them. Solutions may be non-sterile.
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: The FDA has classified this as a Class I recall due to the potential lack of sterility in irrigation solutions. Although no reported illnesses or deaths are documented in the recall notice, the potential for infection from non-sterile irrigation solutions in medical procedures justifies the Severe rating.
Plain-English summary
Medline Industries, LP has issued a recall of 279 units of irrigation and saline kits, trays, and packs due to issues with the components used to manufacture them. The recall affects three product lines: D&C CDS (REF CDS983911J), D&C PACK (REF DYNJ67214F), and D&C PACK (REF DYNJ67214G). These products were manufactured using specific lots of Nurse Assist components, including 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe. Nurse Assist issued a recall of these components due to a potential lack of sterility, which could result in the solutions being non-sterile.
The recalled products have been distributed nationwide throughout the United States, Puerto Rico, Canada, United Arab Emirates, and Panama. Specific lot numbers for each product line have been identified as part of this recall.
Non-sterile irrigation and saline solutions could pose a risk of infection when used in medical procedures.
The recalled product
- Product
- Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- lack-of-sterility
- infection-risk
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 CDS983911J
- UDI/DI 40193489402668 (case)
- 10193489402667 (unit)
- Lot Numbers: 22EBU168
- 22KBI115
- 22LBL299
- 22NBD200
- 22NBF154
- 23ABE617
- 23ABU424
- 23CBT642
- 23IBM022
- 23JBC180
- b) REF DYNJ67214F
- UDI/DI 40195327277803 (case)
- 10195327277802 (unit)
- Lot Numbers: 22LBT250
- 23BBM551
- 23CBS078
- c) REF DYNJ67214G
Distribution
Distributed nationwide across the United States.
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