Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Reported: March 6, 2024 Initiated: November 15, 2023 #Z-1124-2024
Product Description
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Reason for Recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 483 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 483 units.
Why was this product recalled? ▼
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 6, 2024. Severity: Critical. Recall number: Z-1124-2024.
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