Heart and vascular packs recalled because sterilization rationale was not justified
American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; unconfirmed sterility on a cardiac surgery pack is a potential harm and no injuries are reported.
Plain-English summary
American Contract Systems medical procedure kits and trays labelled as Heart Pack (205947), model/item number ANCV78BC; Vascular Pack (232024), model/item number ANVA82AB; and Off Pump CABG Pack (170316), model/item number BHOP48O, are being recalled, along with further kits listed in the notice. Affected kit lot numbers are listed per item, with UDI/DI 00191072235169 for the heart pack. The recall covers 31,506 units distributed in Illinois and Louisiana.
During an internal investigation, American Contract Systems determined that the rationale for sterilization of certain components was not justified and that some components are not fit for further sterilization according to its procedures. As a result, the firm is unable to confirm that product sterilization assurance requirements were met. The FDA classified the action as Class II.
Hospitals and surgical centres holding these lot numbers should quarantine affected stock and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316…
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Procedure Kits
- Affected units
- 31,506
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)
- 1) MODEL/ITEM NUMBER ANCV78BC: UDI/DI 00191072235169
- Kit Lot Numbers: 42-7844511
- 42-8133811
- 42-8037211
- 42-7952411
- 42-7882011
- 2) MODEL/ITEM NUMBER ANVA82AB: UDI/DI 00191072235183
- Kit Lot Numbers: 42-8025011
- 42-8108511
- 42-7928511
- 3) MODEL/ITEM NUMBER BHOP48O: UDI/DI 00191072221490
- Kit Lot Numbers: 9207467
- 8862838
- 9140871
- 9049946
- 9007346
- 8934280
- 4) MODEL/ITEM NUMBER BHOP48P: UDI/DI 00191072234544
- Kit Lot Numbers: 9268782
- 9345847
Distribution
Part of a larger recall action
This product is one of 9 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 9 products in this recall →Related recalls
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