Baxter Recalls PrismaSate Dialysis Solution Bags Due to Leaks
Baxter Healthcare is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy because of leaks near the top of the bags.
The agency’s classification
FDA (Devices): 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: The recall is classified as FDA Class II, and the defect (leaks) in a medical device used for dialysis presents a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Baxter Healthcare Corp. is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy. The recall was initiated due to the presence of leaks near the top of the product bags.
The affected product was distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. The specific lot codes and expiration dates involved are 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), and 1000128164 (04/30/2017).
This is an FDA Class II recall. Healthcare providers and consumers should stop using the affected product and contact Baxter Healthcare for further instructions or a replacement.
The recalled product
- Product
- PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 10,054
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 (6)
- Listing #D051124
- Unique Device Identifier #07332414037048
- Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017)
- 1000128162 (04/30/2017)
- 1000128163 (04/30/2017)
- 1000128164 (04/30/2017).
Distribution
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