FDA Device recall Z-0932-2020
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06 by Datascope, citing potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0932-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-20 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Datascope |
| Distribution | AK, AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV |
Product
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Reason
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Identifiers
| code_info | Part Number: 0684 00 0403 06 UDI: 10607567106656 (0684 00 0403 06) Lot Codes: 3000051658, TLT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0932-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.