PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles
American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.
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: FDA Class II recall involving sterilization validation failure on invasive vascular access devices. No illnesses or injuries reported, but the manufacturing defect creates risk of patient harm through potential compromise of sterility assurance.
Plain-English summary
American Contract Systems, Inc. is recalling various PICC line and central line packs following the discovery of a manufacturing sterilization defect.
The recalled products were exposed to multiple sterilization cycles without validation for multiple exposures. This means the products may not meet the required sterility assurance standards. The recall involves 2 units with specific lot information: Tray LSRPICCLINEH (Lot 2105051, Serial 14886484) and Tray UICL44M (Lot 2107142, Serial 64164800).
The affected products were distributed within the United States to health systems and distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
Healthcare facilities that received these products should immediately discontinue use and contact American Contract Systems, Inc. for return instructions.
The recalled product
- Product
- Various PICC Line, Central Line Packs
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- sterilization-failure
- infection-risk
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 (10)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSRPICCLINEH
- 2105051
- 884211
- 14886484 2) UICL44M
- 2107142
- 807211
- 64164800
Distribution
Distributed in 13 states:
- AZ
- FL
- IA
- IL
- MA
- MN
- MO
- NE
- OH
- PA
- RI
- SD
- TX
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