Public recall detail

Tamper Evident Additive Port Cap

2025-11-13

medium
Recall Safety notice
Quick summary

Quick summary: Tamper Evident Additive Port Cap. Date: 2025-11-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Tamper Evident Additive Port Cap. Date: 2025-11-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandInternational Medical Industries, Inc.
ProductTamper Evident Additive Port Cap
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-81213

Affected products

ProductTamper Evident Additive Port Cap
Lot58203
Model21-01
Serial number58203
DescriptionTamper Evident Additive Port Cap
ProductTamper Evident Additive Port Cap
Lot58590
Model21-01
Serial number58590
DescriptionTamper Evident Additive Port Cap
ProductTamper Evident Additive Port Cap
Lot57325
Model21-01
Serial number57325
DescriptionTamper Evident Additive Port Cap
ProductTamper Evident Additive Port Cap
Lot56586
Model21-01
Serial number56586
DescriptionTamper Evident Additive Port Cap

Issue

The recall was initiated by IMI following their internal discovery that the corrugated shipper box contains incorrect compatibility information. All other information on the box label is correct, including the device label and IFU. Users are advised to not discard or return the device as it is safe to use, and to verify compatibility using the device label and IFU, not the shipper box.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use
CompaniesInternational Medical Industries, Inc. 2981 Gateway Drive, Pompano Beach, Florida, United States, 33069
Recall date2025-10-27
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81213
Background{}
CompaniesInternational Medical Industries, Inc. 2981 Gateway Drive, Pompano Beach, Florida, United States, 33069
AudiencesHealthcare
Source updated2025-11-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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