FDA Device recall Z-1638-2013
- Calf Garment Standard Ref
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II recall of - Calf Garment Standard Ref by Surgical Instrument Service And Savings, citing the seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1638-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-03 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Surgical Instrument Service And Savings |
| Distribution | US |
Product
- Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard Ref. DVT10 Lot 122570, 12546 - Calf Garment, DVT20 Large Ref. DVT20 Lot 122549, 122570 - SCD Express Compression Sleeve, Knee Length, (White) Large Ref. 9789 Lot 122574 - SCD Express Compression Sleeve, Knee Length, (White) Medium Ref. 9529 Lot 122547, 122574 - SCD Express Compression Sleeve, Thigh Length, (White) Medium Ref. 9530 Lot 122574 Compressible limb sleeve. - Thigh Garment DVT30 Medium Ref. DVT30 Lot 122549, 122985 - Thigh Garment DVT40 Large Ref. DVT40 Lot 122549, 122985 - Vaso-Force Intermittent DVT Calf Garment, Large, Calf Sizes up to 24" 24" Ref. MDS601L Lot 122982, 122986 - Vaso-Force Intermittent DVT Calf Garment, Medium, Calf Sizes up to 18" 18" Ref. MDS601M Lot 122986, 122984 - VENAFLOW Calf Cuff, w/Foam (White) 19" Max. Calf Circumference Ref. 3010-PL Lot 122692, 122715
Reason
The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Identifiers
| code_info | 122692, 122982, 122986, 122984, 122549, 122985, 122570, 122546, 122547, 122574, 122715. |
|---|
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-1638-2013%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.