Fresenius Kabi 250 mL saline freeflex bags recalled over sterility assurance
Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP supplied in 250 mL freeflex bags under its own label, citing lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no illnesses reported in the source.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 0.9% Sodium Chloride Injection, USP, 2,250 mg per 250 mL (9 mg per mL), supplied as 250 mL in a 250 mL freeflex bag. The unit of use NDC is 65219-470-05 and the unit of sale NDC is 65219-470-30.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into the bloodstream or tissue. The FDA classified the action as Class II.
Distribution was US nationwide, including Alaska and Puerto Rico. Affected batch numbers are listed in the recall notice.
This is a prescription product supplied to healthcare facilities. Facilities should check stock against the batch numbers in the recall notice, quarantine affected bags and follow the instructions issued by Fresenius Kabi.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable solution
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)
- Batch# 23SU10008
- Exp Date: 12/31/2026
- Batch# 24JU10003
- Exp Date: 07/31/2027
- Batch# 24LU10011
- 24LU10012
- Exp Date: 9/30/2027
- Batch# 6402273
- 6402275
- Exp Date: 01/31/2028
- Batch# 6402420
- 6402421
- 6402422
- 6402423
- Exp Date: 03/31/2028
- Batch# 6402473
- 6402474
- 6402475
- 6402476
- 6402485
Distribution
Part of a larger recall action
This product is one of 14 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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