Baxter MiniCap Extended Life PD Transfer Set Recalled for Leak Risk
Baxter Healthcare is recalling 72,771 units of MiniCap Extended Life PD Transfer Sets due to a potential for no-flow and leaks under the twist clamp.
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 hazard involves a risk of harm (no-flow and leaks) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 72,771 units of the MiniCap Extended Life PD Transfer Set. The recall was initiated because of a potential for no-flow and leaks under the twist clamp. The affected product is identified by Product Code 5C4482 and UDI 00085412007731.
The recalled units were distributed worldwide and in the US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia. The specific lots affected include H20D13100, H20D27084, H20D30070, H20E13107, H20E19054, H20E22082, H20F09061, H20F15050, H20F18070, H20F24086, H20F29051, H20G13046, H20G27087, H20G30065, H20H05057, H20H14067, and H20H19066, with expiration dates ranging from April 13, 2025, to August 19, 2025.
Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be stopped and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- MiniCap Extended Life PD Transfer Set
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 72,771
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)
- Product Code: 5C4482
- UDI: 00085412007731
- Lot#
- Expiration Date: H20D13100
- 4/13/2025
- H20D27084
- 4/27/2025
- H20D30070
- 4/30/2025
- H20E13107
- 5/13/2025
- H20E19054
- 5/19/2025
- H20E22082
- 5/22/2025
- H20F09061
- 6/9/2025
- H20F15050
- 6/15/2025
- H20F18070
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
Same hazard · leak
See all →- SevereFresenius Medical Care Recalls 5008X Standard HD Pre-Flush Blood Tubing Sets
FDA (Devices) · 2026-09-09
- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits with Recalled Swan-Ganz Catheters
FDA (Devices) · 2026-07-08
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
Similar recalls
- HighBaxter MiniCap PD Transfer Sets Recalled Due to Damage from Cleaning Products
FDA (Devices) · 2022-02-16
- HighBaxter PD Transfer Set Recall: Risk of Leaking or Cracking
FDA (Devices) · 2022-02-16
- SevereBaxter MiniCap PD Transfer Set Recalled for Connection Leak Risk
FDA (Devices) · 2017-06-14
- HighBaxter PD Transfer Sets Recalled Due to Chemical Damage Risk
FDA (Devices) · 2022-02-16
- HighBaxter MiniCap PD Transfer Sets Recalled for Chemical Damage Risk
FDA (Devices) · 2022-02-16
- HighBaxter PD Transfer Sets may leak or crack from common cleaning products
FDA (Devices) · 2022-02-16