The Recall Desk
HighFDA (Devices)·Z-0768-2021·Announced 2021-01-13

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.

What this means for you

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
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.