FDA Device recall Z-2360-2014
C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANK…
- FDA Device
- Class I
- terminated
- Published 2014-09-10
On 2014-09-10 the FDA classified a Class I recall of C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANK… 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-2360-2014 |
| 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
C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR (1) CORD UMBILICAL CLAMP (2) LIGHT GLOVE (1) BOWL UTILITY 32oz (1) BOWL UTILITY 16oz (4) DRAPE UTILITY (1) TUBE SUCTION CONNECT. 1!4" X 12' (1) TIP CAUTERY POLISHER (1) MUCUSTRAP 20cc, 10FR. (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) PENCIL CAUTERY ROCKER SWITCH (1) ELECTRODE DUAL DEPRES./GROUNDPAD (1) C-SECTION DRAPE WITH POUCH 102" X 121" X 78" (1) EAR ULCER SYRINGE 2oz (1) BABY BEANNIES (1) RECEIVING BLANKET 100% COTTON (2) SURGICAL BLADE #10 STAINLESS STEEL 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 900-921A, 4 lots: 140312028 140412706 140513148 140513469 |
|---|
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-2360-2014%22
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