FDA Device recall Z-2104-2012
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK
- FDA Device
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK by Intuitive Surgical, citing specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2104-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-13 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Reason
Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have difficulty engaging an instrument.
Identifiers
| code_info | Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D1…Part number: 420290-03 Lot numbers: D120735,,D120745,D120815, D120815A, D120885, D120895, D120905 D120945, D120955, D120955A, D120965, D121025, D121035, D121045, D121075, D121075A, D121095, D121155, D121165, D121165A, D121215. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2104-2012%22
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