Delivery Pack Medical Device Sterilization Assurance Not Confirmed
American Contract Systems Inc is recalling Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) because sterilization assurance requirements were not confirmed. Unsterilized devices may not function properly and could delay treatment.
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 FDA recall for a medical device with potential sterilization failure. Sterilization assurance failure represents a risk of harm from infection or device malfunction, but no illnesses or injuries have been reported. The rubric applies Score 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems Inc is recalling 36 kits of Delivery Pack medical devices (Models SGDV22D-01 and SGDV22E) that were distributed in Ohio. The company was unable to confirm that sterilization assurance requirements were met during manufacturing of these devices.
Medical devices that do not meet sterilization assurance may lose or lack functionality. If the devices do not function properly, this could lead to delay or prolonged treatment for patients who depend on them.
The recalled devices are identified by lot numbers 70-051227 and 70-052347. The devices can be identified by UDI-DI 00191072223685 and 00191072230164.
The recalled product
- Product
- DELIVERY PACK , Model No SGDV22D-01 SGDV22E
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Sterilization
- Affected units
- 36
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 (1)
- UDI-DI 00191072223685 00191072230164 Lots 70-051227 70-052347
Distribution
Part of a larger recall action
This product is one of 32 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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