Baxter Recalls Clinimix E Bags Due to Dried Skin Particulate Matter
Baxter Healthcare is recalling 7,436 bags of Clinimix E injection due to the presence of dried skin particulate matter. The product was distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I', which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 7,436 bags of CLINIMIX E 5/15 sulfite-free Injection, 1000 mL, due to the presence of particulate matter identified as dried skin. The affected product is a prescription-only intravenous solution containing amino acids, electrolytes, and dextrose, manufactured by Baxter Healthcare Corporation in Deerfield, IL.
The specific lot involved is P333930, with an expiration date of 05/31/2017. The product was distributed nationwide and in Puerto Rico. The recall is classified as FDA Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
Healthcare providers and consumers should stop using the affected product immediately. Patients who have received this product should contact their healthcare provider for guidance. Baxter Healthcare is the firm responsible for the recall.
The recalled product
- Product
- CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
- Brand
- CLINIMIX E
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Nutrition
- Affected units
- 7,436
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 (2)
- Lot #: P333930
- Exp 05/31/2017
Distribution
Part of a larger recall action
This product is one of 4 recalled by Baxter Healthcare Corp. 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 4 products in this recall →Related recalls
Same brand · CLINIMIX E
- SevereBaxter Recalls Clinimix E Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-04-08
- HighBaxter Recalls Clinimix E IV Bags Due to Sterility Concerns
FDA (Drugs) · 2014-12-24
- SevereBaxter Recalls Clinimix E IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- CriticalBaxter Recalls Clinimix E Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
Same manufacturer · Baxter Healthcare Corp.
See all →- HighBaxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
FDA (Devices) · 2017-09-20
- ModerateBaxter Recalls SIGMA Spectrum Infusion Pump Rear Case Assemblies
FDA (Devices) · 2016-12-07
- ModerateBaxter SIGMA Spectrum Infusion Pump Recall for Speaker Failure
FDA (Devices) · 2016-12-07
- ModerateBaxter Recalls Sigma Spectrum Infusion Pumps Due to Speaker Failure Risk
FDA (Devices) · 2016-12-07
- HighBaxter Recalls Revaclear MAX Dialyzers Due to Potential Particulate Matter
FDA (Devices) · 2016-11-16
Same hazard · particulate matter
See all →- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- CriticalBaxter Recalls Clinimix E Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- SevereBaxter Recalls Clinimix E IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- HighBaxter Recalls Clinimix E IV Bags Due to Sterility Concerns
FDA (Drugs) · 2014-12-24
- CriticalBaxter Recalls Clinimix IV Bags Due to Particulate Matter
FDA (Drugs) · 2014-03-26
- SevereBaxter Recalls Clinimix E Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-04-08
- HighBaxter Recalls ProSol Amino Acid Injection Due to Particulate Matter
FDA (Drugs) · 2014-08-27