FDA Device recall Z-1400-2015
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 61…
- FDA Device
- Class II
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class II recall of CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 61… by Civco Medical Instruments, citing leaks were detected in the recalled lot which may compromise the sterility of the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1400-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-26 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Civco Medical Instruments |
| Distribution | CA, IL, MA, MI, MO, WI |
Product
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
Reason
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Identifiers
| code_info | Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01 |
|---|
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-1400-2015%22
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