Z-2170-2020Class II
Sterile Custom Packs to be used in surgical procedures
American Contract Systems, Inc. / initiated 2020-04-13 / Terminated / root cause: manufacturing process
American Contract Systems began a recall of Sterile Custom Packs to be used in surgical procedures on . FDA classified it as Class II and gives the reason as "The surgical gowns were manufactured in a facility that is not registered by the FDA". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2170-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- American Contract Systems, Inc.
- Product
- Sterile Custom Packs to be used in surgical procedures.
- Product code
- LRO General Surgery Tray
- Reason for recall
- The surgical gowns were manufactured in a facility that is not registered by the FDA.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Notification to the distributor and instructed them to notify its customers (hospitals) of the recall and product removal.
- Quantity in commerce
- 2,868 kits
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Product codes and lots
- ACS Tray Numbers: WPPP52E; Lot # 723191, Exp. Date 10/04/2020 (24 kits) AGMM60M; Lot # 656191, Exp. Date 12/10/2020 (20 kits) VSMI14G; Lot # 643191, Exp. Date 12/23/2020 (60) and Lot #71891, Exp. Date 10/09/2020 (6 kits) WXOLO48H; Lot # 654191, Exp. Date 12/12/2020 (6 kits) AGKD5OJ; Lot # 997201, Exp. Date 01/03/2021 (26 kits) AGME44J; Lot # 997201, Exp. Date 01/03/2021 (24 kits) AGMA31K; Lot # 642191, Exp. Date 12/24/2020 (96 kits) AGMI141; Lot # 671191, Exp. Date 11/25/2020 (36 kits) and Lot # 789191, Exp. Date 07/30/2020 (14 kits) AVMA31I; Lot # 675191, Exp. Date 11/21/2020 (2 kits) AVMI14H; Lot # 639191, Exp. Date 12/27/2020 (70 kits) WXMI14H; Lot # 650191, Exp. Date 12/16/2020 (160 kits) AGLO48H; Lot # 670191, Exp. Date 11/26/2020 (30 kits) SVMA21I; Lot # 654191, Exp. Date 12/12/2020 (30 kits)
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2166-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2167-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2168-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2169-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2170-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2171-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2172-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2173-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2174-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2175-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2176-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2177-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2178-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2179-2020 | Class II | Terminated | Voluntary: Firm initiated |
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