Port Insertion Packs Recalled Due to Unvalidated Sterilization
American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.
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: This is a Class II medical device recall involving theoretical risk of improper sterilization due to unvalidated sterilization cycles. No illnesses, injuries, or confirmed contamination have been reported, placing this as a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
American Contract Systems, Inc. is recalling Various Port Insertion Packs distributed to health systems and medical distributors across the United States. The devices were exposed to multiple sterilization cycles without validation of the sterilization process for repeated exposures, meaning the sterility and safety of the devices cannot be confirmed.
The affected devices were distributed to facilities in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. Specific lot numbers and serial numbers have been identified for the recall.
Health systems and distributors should immediately quarantine and remove any of these devices from clinical use or inventory. Facilities should contact American Contract Systems or the FDA for instructions on device replacement, reprocessing procedures, or proper disposal.
The recalled product
- Product
- Various Port Insertion Packs
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 2
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 (8)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) GSPI26E
- 2108202
- 770211
- 44336884-005 2) GSPI26E
- 44336909-005
Distribution
Part of a larger recall action
This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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