Agency classClass IIOur severity:High FDA (Devices)·Z-1699-2022·Announced 2022-09-14

Surgical instrument convenience packs recalled for inadequate sterilization validation

American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.

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 FDA Class II recall involves surgical instruments exposed to multiple sterilization cycles without validation of adequate sterilization. Although no illnesses or injuries have been reported, improperly sterilized surgical instruments represent a significant risk of harm through potential infection; therefore this meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

American Contract Systems, Inc. is recalling various convenience packs of surgical and orthopedic instruments totaling 118 units. The products were exposed to multiple sterilization cycles without validation that the instruments could withstand repeated sterilization. This represents a deviation from required sterilization standards.

The recalled products were distributed 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 convenience packs should stop using them and contact American Contract Systems, Inc. for instructions on replacement or return. Patients and healthcare providers should consult with their medical team regarding any procedures performed with these instruments.

The recalled product

Product: Various convenience packs
Manufacturer: American Contract Systems, Inc.
Category: Medical Device — Surgical Instruments
Hazard: sterilization-failure
infection-risk
Affected units: 118

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)

Tray Number
Sterilization Lot
Lot Number
Bag Serial Number 1) LSRHUMTOTPKC
2104192
894211
14881385 2) LSRLMHANDA
2104221
901211
64119577 3) LSRHUMTOTPKC
14881385 4) LSRTOTJOINTM
2104301
888211
63993926 5) LSRTOTJOINTM
63993926 6) LSRLMHANDA
2105101
883211
63991195 7) LSRORTHOMINH
2107221
818211

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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