Agency classClass IIOur severity:High FDA (Devices)·Z-1692-2022·Announced 2022-09-14

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.

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: 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
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 (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:

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.

See all 17 products in this recall →

Same manufacturer · American Contract Systems, Inc.

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