| Date Initiated by Firm |
May 20, 2014 |
| Date Posted |
August 29, 2014 |
| Recall Status1 |
Terminated 3 on August 14, 2017 |
| Recall Number |
Z-2434-2014 |
| Recall Event ID |
68536 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product |
NEURO SPINE PACK
CONTENTS: (1) SUTURE BAG FLORAL LIF
(1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF
(1) SHEET 'I" 60" X 77" DRAPE REINF. LIF
(2) SPECIMEN CONTAINER 4oz W/LID & LABEL
(2) CUP MEDICINE 2oz UF
(2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL
(20) GAUZE SPONGE 4" X 4" 16ply XRD UF
(5) SPONGE LAP PREWASH 18"X 18" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF
(1) YANKAUER SUCT. TUBE W/0 VENT LIF
(1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) POLISHER CAUTERY TIP LIF
(2) PENCIL CAUTERY HAND SWITCHING LIF
(1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP
(2) BLADE SURG #15 CARBON STEEL
(1) PK.STRIP SURGICAL %" X 6" COTTON (1) PK.STRIP SURGICAL Y4" X 6" COTTON (10) GAUZE SPONGE 4" X 4" 16ply
(1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt
(4) SHEET DRAPE 42" X 57" SMS LIF
(2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz.
(2) SYRINGE EAR/ULCER 2oz LIF
(2) BLADE EXTENDED ELECTRODE
(2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR
(1) STRIP SURGICAL 'I"X 6"
(2) GOWN XL SMS IMPERV. REINFORCED UF
(1) CORD BIPOLAR FIRCEPS
(4) TOWEL CLOTH HUCK (WHITE)
(2) DRESSING OPSITE POST PO 2%" x 2" (2) POUCH INSTRUMENT 7 X 11
(1) MAYO TRAY LARGE
(1) MAYO STAND COVER REINFORCED UF
Product Usage:
EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
|
| Code Information |
Product code 900-2122, 1 lot: 112124868 |
Recalling Firm/
Manufacturer |
Customed, Inc
Calle Igualdad Final #7
Fajardo PR 00738
|
| For Additional Information Contact |
Rosemari Melendez
787-622-5151 Ext. 7540
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Package design/selection |
| Action |
Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit.
Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540 |
| Quantity in Commerce |
1 lot/15 units |
| Distribution |
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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