CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report
Custom Packs to be used in surgical procedures recalled
American Contract Systems is recalling Custom Packs to be used in surgical procedures, distributed nationwide in the US. The recall was initiated on 13 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2168-2020
- FDA event ID
- 85502
- Recalling firm
- American Contract Systems, Zelienople, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2020
- FDA classified
- 29 May 2020
- Reported
- 10 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 13 Apr 2020 | Recall initiated by company | |
| 29 May 2020 | Classified by FDA | +46 days |
| 10 Jun 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Product as listed by the FDA
Custom Packs to be used in surgical procedures.
Where it was distributed
US Nationwide distribution including in the state of Pennsylvania.
Questions about this recall
Is Custom Packs to be used in surgical procedures recalled?
Yes. American Contract Systems recalled Custom Packs to be used in surgical procedures on 13 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2168-2020.
Why was it recalled?
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Which lots are affected?
WPGA21L; Lot # 998201, Exp. Date 01/02/2021 (24 kits) and Lot # 6781914, Exp date 11/18/2020 (4 kits) AGGL48H; Lot# 643191, Exp. Date 12/23/2020 (80 kits) AGGM59N: Lot # 761191, Exp. Date 08/27/2020 (5 kits)
Where was it sold?
US Nationwide distribution including in the state of Pennsylvania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |