FDA Device recall Z-2356-2014
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd by Customed, citing customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2356-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-05-20 |
| Published | 2014-09-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Customed |
| Distribution | US |
Product
ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4) STRIPS TAPE 24" X 4" L/F (1) STOCKINETTE 6" X 48" LIF (1) MAYO TRAY SMALL (5) HUCK CLOTH TOWELS BLUE (2) UTILITY BOWL 32oz (2) GOWN SURGICAL REINFORCED X-LARGE LEVEL IV (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) SHEET EXTREMITY ABS. 125" x 85" SMS (5) LAP SPONGE PREWASH XRD (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) PENCIL CAUTERY ROCKER SWITCH (1) SKIN MARKER INK WITH 8 LABEL (2) LITES GLOVES UF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR (1) CAUTERY TIP POLISHER UF (4) DRAPE UTILITY WITH TAPE UF (1) BAG BIOHAZARD 30" X 37" (1) BAG SUTURE FLORAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE TOWEL/WRAP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason
Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Identifiers
| code_info | Product code 900-902, 11 lots: 112041360 112051755 112052021 113015521 113025983 113036389 113067942 113078352 140312189 140412917 140513342 |
|---|
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-2356-2014%22
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