LAPAROSCOPY PACK — Class I medical device recall Z-2424-2014
Terminated recall by Customed, Inc, reported 2014-09-10, distributed nationwide. Customed has determined that there is the possibility that packaging integrity may be compromised on different
| Recall number | Z-2424-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Customed, Inc, Fajardo, PR, United States |
| Recall initiated | 2014-05-20 |
| Classified | 2014-08-29 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2017-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CR, DO, MX, TT |
| Reason classes | sterility, packaging |
| Lot numbers | 111123453, 112030696, 112041219, 112041457, 112051908, 112062470, 112083417, 112125164, 113015692, 113025952, 113026107, 113026233, 113047010, 113057694, 113078292, 140211807, 140312103, 140412626, 140412893 |
Product
LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18" X 18" XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F (2) SHEET DRAPE 42" X 57" SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2" X 2" 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2424-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.